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Medical Devices

October 2014 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P130024
10/9/14
Lutonix 035 Drug Coated Balloon PTA Catheter Lutonix, Inc.
New Hope, MN 55428
Approval for the Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB). This device is indicated for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.
P130026
10/24/14
TactiCath Quartz® Catheter and TactiSysQuartz® Equipment St. Jude Medical
St. Paul, MN
55117
Approval for the TactiCath Quartz® Catheter and TactiSysQuartz® Equipment. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810002/S090
10/7/14
135-Day
St. Jude Medical Mechanical Heart Valve, SJM Masters Series Mechanical Heart Valve, SJM Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff, SJM Masters Series Mechanical Heart Valve with PTFE Sewing Cuff, SJM Masters Series Mechanical Heart Valve with Expanded PTFE Sewing Cuff, SJM Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff,
SJM Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff,
SJM Masters Series Mechanical Heart Valve with HP Flex Cuff, SJM Regent Heart Valve, SJM Regent Heart Valve with Flex Cuff,
SJM Masters Series Aortic Valved Graft with Hemashield Graft Technology,
SJM Masters HP Valved Graft with Gelweave Valsalva Technology
St. Jude Medical, Inc.
St. Paul, MN
55117
Approval for transfer of a component manufacturing process to Caguas, Puerto Rico.
P810006/S049
10/31/14
135-Day
Collastat Absorbable Collagen Hemostatic Sponge Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for a change in cleaning validation process for manufacturing equipment.
P810006/S053
10/17/14
135-Day
CollaStat Absorbable Collagen, Hemostatic Sponge
CollaStat, Absorbable Collagen, Hemostatic Agent-Microfibrillar Form
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico for the devices.
P840062/S036
10/31/14
135-Day
CollaCote and CollaTape Absorbable Collagen Wound Dressings for Dental Surgery Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for a change in cleaning validation process for manufacturing equipment.
P840062/S040
10/17/14
135-Day
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico for the devices.
P850010/S047
10/31/14
135-Day
Helistat Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for a change in cleaning validation process for manufacturing equipment.
P850010/S053
10/17/14
135-Day
HeliStat, Helitene Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico for the devices.
P850048/S039
10/24/14
Real-Time
Access Hybritech Total PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the Access Substrate bottle and cap.
P860004/S206
10/20/14
180-Day
SYNCHROMED LIORESAL INFUSION PUMP Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the Model 8835 myPTM used with the Medtronic SynchroMed II Programmable Drug Infusion System.
P880086/S247
10/10/14
Real-Time
Assurity/Endurity Families of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for minor design modifications to the IS-1 lead bores for the devices.
P890064/S031
10/9/14
Real-Time
Qiagen Digene Hybrid Capture 2 (HC2) HPV DNA Test, Qiagen Digene Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.
Gaithersburg, MD 20878
Approval for the upgrade of the HC2 Software Suite to version 4.3.
P900033/S035
10/17/14
135-Day
Integra Dermal Regeneration Template Integra LifeSciences Corporation
Plainsboro, NJ 08536
Approval for the implementation of mechanical, program, and system control changes to the existing Chilled Water System that services collagen lyophilizer machines in the LYO Manufacturing Area of Building 1 at the Integra NeuroSciences facility in Añasco, Puerto Rico, for the devices.
P910001/S072
10/9/14
Real-Time
Excimer Laser Coronary Atherectomy Catheter Spectranetics Corporation
Colorado Springs, CO
80921
Approval for parametric release for the devices.
P910023/S344
10/10/14
Real-Time
Ellipse Family of ICDs St. Jude Medical
Sylmar, CA
91342
Approval for minor design modifications to the IS-1 lead bores for the devices.
P910062/S007
10/2/14
Real-Time
STAR Excimer Laser System and WaveScan WaveFront Laser System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Approval for redesign of the STAR thyratron trigger board (P/N 0040-0044).
P920047/S071
10/17/14
180-Day
Maestro 3000 Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California.
P930016/S043
10/2/14
Real-Time
STAR Excimer Laser System and WaveScan WaveFront Laser System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Approval for redesign of the STAR thyratron trigger board (P/N 0040-0044).
P930039/S107
10/13/14
180-Day
CapSureFix Novus MRI SureScan Lead Medtronic, Inc.
Mounds View, MN 55112
Approval for adding the 5076 CapSureFix Novus Lead to the MR Conditional pacing family. The device, as modified, will be marketed under the trade name CapSureFix Novus MRI SureScan Model 5076 and is indicated for use as a system consisting of a Medtronic MRI SureScan IPG implanted with SureScan leads. A complete system is required for use in the MRI environment.
P950029/S097
10/23/14
Special
Reply SR, Reply DR, Esprit SR, and Esprit DR Families of Pacemakers Sorin CRM USA, Inc.
Arvada, CO
80004
Approval for modifications to the implant manuals in alignment with a previous safety communication.
P960009/S203
10/24/14
Real-Time
ACTIVA IMPLANTABLE NEUROSTIMULATORS Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for a material change to the white DBS boot.
P960042/S049
10/9/14
Real-Time
Spectranetics Laser Sheath Kits Spectranetics Corporation
Colorado Springs, CO
80921
Approval for parametric release for the devices.
N970003/S167
10/21/14
180-Day
Ingenio™ Pacemakers (ADVANTIO™, INGENIO™,
FORMIO™); Ingenio™ 2 Pacemakers (ALTRUA 2™, ESSENTIO™,
PROPONENT™, ACCOLADE™
Boston Scientific Corporation
St. Paul, MN
55112
Approval for Ingenio™ Pacemakers (ADVANTIO™ Models K062, K063, K064; INGENIO™ Models K172, K173, K174; VITALIO™ Models K272, K273, K274; FORMIO™ Model K278); Ingenio™ 2 Pacemakers (ALTRUA 2™ Model: S701, S702, S722; ESSENTIO™ Models L100, L101, L121; PROPONENT™ Models L200, L201, L221; ACCOLADE™ Models L300, L301, L321) and Programmer Application Software Model 2869 v2.01.
P970004/S172
10/17/14
180-Day
Medtronic InterStim Therapy for Urinary Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the Model 3037 iCon Patient Controller used for Medtronic InterStim Therapy for Urinary Control and Bowel Control.
P970038/S028
10/24/14
Real-Time
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the Access Substrate bottle and cap.
P980003/S050
10/17/14
180-Day
Maestro 3000 Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California.
P980016/S503
10/2/14
Real-Time
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD,
Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Approval for a battery design change and associated inspection and production tooling changes.
P980022/S156
10/2/14
135-Day
Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System,
Guardian REAL-Time System,
MiniLink REAL-Time Continuous Glucose Monitoring System, iPro2 Professional Continuous Glucose Monitoring System
Medtronic Minimed Northridge, CA 91325 Approval for a change to replace the current holder (blue test plug) used as a production aid during sub-assembly manufacturing of the MiniLink (MMT-7703) and iPro2 (MMT-7741) transmitters to two new holders. The MiniLink transmitter is a component of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time and MiniMed 530G Systems. The iPro2 transmitter is a component of the iPro2 Professional Continuous Glucose Monitoring System.
P980022/S160
10/8/14
135-Day
Paradigm REAL-Time and Paradigm REAL-Time Revel Continuous Glucose Monitoring
Systems
Medtronic Minimed
Northridge, CA 91325
Approval for a change to a supplier’s production line for a motor part of the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723 and MMT-723K) and the MiniMed 530G Insulin Pumps (models MMT-551 and MMT-751). The insulin pumps are components of the Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, and the MiniMed 530G System respectively.
P980041/S029
10/24/14
Real-Time
Access AFP Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the Access Substrate bottle and cap.
P990010/S007
10/2/14
Real-Time
STAR Excimer Laser System and WaveScan WaveFront Laser System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Approval for redesign of the STAR thyratron trigger board (P/N 0040-0044).
P990065/S007
10/9/14
Special
SIR-Spheres® Microspheres Sirtex Medical Limited
North Sydney,
AUSTRALIA
2060
Approval for an optional use of an alternate non-ionic solution 5% Dextrose (D5W).
P000008/S028
10/7/14
180-Day
LAP-BAND® Adjustable Gastric Banding System Apollo Endosurgery, Inc.
Austin, TX
78746
Approval for design changes to the RapidPort EZ Access Port, design changes to the RapidPort EZ Access Port Applier, and packaging changes.
P000037/S036
10/28/14
135-Day
On-X Prosthetic Heart Valve On-X Life Technologies, Inc.
Austin, TX
78752
Approval for vertical integration of a component substrate manufacturing process.
P000039/S048
10/29/14
180-Day
AMPLATZER Septal Occluder (ASO) and Cribiform Occluder (ASD-MF) AGA Medical Corporation
Plymouth, MN 55442
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish.
P010013/S058
10/28/14
180-Day
NovaSure Impedance Controlled Endometrial Ablation Device Hologic, Inc.
Marlborough, MA 01752
Approval for device modifications, including flattening of the NVSRAM battery clip and addition of Kapton tape to the NVSRAM battery and the UI Board shield to overcome a device error  occurring if contact of these components occurs.
P010031/S467
10/2/14
Real-Time
Concerto II CRT-D, Consulta ICD,
Maximo II CRT-D, Protecta CRT-D,
Protecta XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for a battery design change and associated inspection and production tooling changes.
P010032/S083
10/15/14
Real-Time
St. Jude Spinal Cord Stimulation System St. Jude Medical
Plano, TX
75024
Approval for minor design changes to the Single 8 Extension (Model 3383) to introduce a new 8-Channel Adapter (Models 2311 and 2316) for Spinal Cord Stimulation (SCS) Systems. The new 8-Channel Adapter is intended to connect a compatible 8- channel Medtronic lead or extension to a St. Jude Medical implantable pulse generator.
P020009/S123
10/10/14
135-Day
Express2® Coronary Stent System (Monorail® & Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a software upgrade to update the radio frequency identification (RFID) reading software.
P020024/S038
10/29/14
180-Day
AMPLATZER Duct Occluder (ADO) AGA Medical Corporation
Plymouth, MN 55442
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish.
P020025/S059
10/17/14
180-Day
Maestro 3000 Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Approval for a manufacturing site located at Stellartech Research Corporation, in Milpitas, California.
P020026/S086
10/10/14
180-Day
Cypher Sirolimus-Eluting Coronary Stent Cordis Corporation
Fremont, CA
94555
Approval of the post-approval study protocol.
P020045/S059
10/1/14
Real-Time
Freezor Cardiac Cryoablation System Medtronic CryoCath LP
Mounds View, MN 55112
Approval to update the leak detection firmware.
P020045/S060
10/23/14
Real-Time
7F FREEZOR CARDIAC CRYOABLATION CATH.&  XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM Medtronic Cryocath, LP
Quebec, Canada
H9R 5Z8
Approval for a modified check valve in the CryoConsole.
P030005/S113
10/21/14
180-Day
Ingenio™ CRT-P Devices (INVIVE™ CRT-P, INTUA™ CRT-P); Ingenio™ 2 CRT-P Devices (VALITUDE™,
VALITUDE™ X4)
Boston Scientific Corporation
St. Paul, MN
55112
Approval for Ingenio™ CRT-P Devices (INVIVE™ CRT-P Models V172, V173; INTUA™ CRT-P Models V272, V273); Ingenio™ 2 CRT-P Devices (VALITUDE™ Model U125; VALITUDE™ X4 Model U128).
P030006/S026
10/24/14
135-Day
Prolieve Thermodilatation System Medifocus Incorporated
Columbia, MD 21046
Approval for replacing the current supplier for manifold tubing, and to replace medical device adhesive currently used in manufacturing.
P030017/S203
10/2/14
Special
Precision ® and Precision SpectraTM Spinal Cord Stimulator (SCS) Systems Boston Scientific Neuromodulation
Valencia, CA
91355
Approval for a labeling change to be made to the Precision and Precision Spectra Manuals. The requested change adds supplemental information to the Adverse events section of the manuals in order to provide additional details on the possibility of the formation of reactive tissue around the lead in the epidural space which may result in delayed onset of spinal cord compression and neurological/sensory deficit including paralysis.
P030035/S125
10/10/14
Real-Time
Allure Family of CRT-Ps St. Jude Medical
Sylmar, CA
91342
Approval for minor design modifications to the IS-1 lead bores for the devices.
P030049/S011
10/28/14
Real-Time
ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur®HBsAg Confirmatory ReadyPack Reagents and ADVIA Centaur®HBsAg Quality Control Material Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY 10591
Approval for the addition of two washes of the ancillary probe on the ADVIA Centaur and ADVIA Centaur XP instruments when the ADVIA Centaur HBsAg assay is run immediately following the ADVIA Centaur Syphilis assay.
P030050/S017
10/10/14
180-Day
Sculptra Galderma Laboratories, L.P.
Fort Worth, TX 76177
Approval for a change in product labeling to describe the results of a Post Approval Study in patients with HIV associated Lipoatrophy.
P030053/S014
10/1/14
180-Day
MemoryGel Silicone Gel-Filled Breast Implants Mentor Worldwide, LLC.
Santa Barbara, CA 93111
Approval of the post-approval study protocol.
P040001/S022
10/24/14
180-Day
X-STOP Interspinous Process Decompression System Medtronic Sofamor Danek USA, Inc.
Memphis, TN 38132
Approval of the post-approval study protocol.
P040013/S019
10/21/14
135-Day
GEM 21S Luitpold Pharmaceuticals Incorporated
Norristown, PA 19403
Approval for a new filtration step and renovations at the Shirley, New York manufacturing facility.
P040040/S022
10/29/14
180-Day
AMPLATZER VSD Muscular Occluder (VSD-Musc) AGA Medical Corporation
Plymouth, MN 55442
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish.
P040043/S067
10/21/14
180-Day
Gore TAG Thoracic Endoprosthesis W. L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Approval for an update to the labeling for the Gore TAG Thoracic Endoprosthesis to reflect the findings of the Post-Approval Study.
P050023/S078
10/10/14
Real-Time
Ilesto 7 VR-T, Ilesto 5 VR-T, Ilesto 5 VR-T DX, Iforia 7 VR-T, Iforia 7 VR-T DX, Ilesto
7 DR-T, Ilesto 5 DR-T, Iforia 7 DR-T and Iforia 5 DR-T ICDs; Ilesto 7 HF-T, Iforia 7 HF-T, Ilesto 5 HF-T and Iforia 5 HF-T CRT-Ds
Biotronik, Inc.
6024 Jean Road
Lake Oswego, OR 97035
Approval for a Modified Dump Resistor for the Ilesto/Iforia families of ICDs/CRT-Ds.
P050034/S013
10/8/14
180-Day
Implantable Miniature Telescope™
(IMT) Models Wide Angle 2.2X, and
Wide Angle 2.7X
VisionCare Ophthalmic Technologies, Inc.
Saratoga, CA
95070
Approval to modify the indications for use for the IMT to include patients 65 to 74 years of age from the current minimum of 75 years, to revise the professional and patient labeling to update the data based on the results out to 8-years post IMT implantation, and to revise the acceptance of risk and informed decision agreement, as well as the professional and patient labeling, to emphasize that the longer the IMT is in the eye, the greater the potential risk of developing vision-impairing corneal edema which may lead to the need for corneal transplant and possible telescope removal.  The device, as modified, will be marketed under the trade name Implantable Miniature Telescope™ (by Dr. Isaac Lipshitz) (IMT) Models Wide Angle 2.2X and Wide Angle 2.7X and is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular degeneration.  Patients must: 1) have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography; 2) have evidence of visually significant cataract (> Grade 2); agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision; 3) achieve at least a 5-letter improvement on the ETDRS chart with an external telescope; 3) have adequate peripheral vision in the eye not scheduled for surgery; and 5) agree to participate in postoperative visual training with a low vision specialist.
P050037/S050
10/24/14
135-Day
Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Approval for changes to the sterilization process for the Radiesse Dermal Filler.
P050052/S055
10/24/14
135-Day
Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Approval for changes to the sterilization process for the Radiesse Dermal Filler.
P060006/S060
10/10/14
135-Day
Express® SO Renal Monorail® Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a software upgrade to update the radio frequency identification (RFID) reading software.
P060033/S092
10/17/14
Real-Time
Endeavor Sprint Zotarolimus Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Approval of updates to the Instructions for Use to accurately reflect the correct safety factors for the Zotarolimus drug substance.
P070015/S122
10/3/14
Panel-Track
XIENCE V® and XIENCE nano® Everolimus Eluting Coronary Stent System Abbott Vascular, Inc.
Santa Clara, CA 95054
Approval for the expansion of the indications for use of the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System to include de novo total coronary occlusions.. These devices are indicated for the following: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System The XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 28mm) with reference vessel diameters of 2.25mm to 4.25mm. Additionally, the XIENCE V stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System.  The XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE PRIME stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System The XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Alpine Everolimus Eluting Coronary Stent System.  The XIENCE Alpine Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions.
P080009/S002
10/7/14
180-Day
Sedasys Computer-Assisted Personalized Sedation System Ethicon Endo-Surgery, Inc.
Cincinnati, OH 45242
Approval of the post-approval study protocol.
P080025/S068
10/17/14
180-Day
Medtronic InterStim Therapy for Bowel Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the Model 3037 iCon Patient Controller used for Medtronic InterStim Therapy for Urinary Control and Bowel Control.
P080027/S018
10/2/14
Special
OraQuick® HCV Rapid Antibody Test OraSure Technologies, Incorporated
Bethlehem, PA 18015
Approval for the addition of an in-process inspection as part of the pouching process for the OraQuick® HCV Rapid Antibody Test.
P090003/S032
10/10/14
135-Day
Express® LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a software upgrade to update the radio frequency identification (RFID) reading software.
P090003/S035
10/10/14
Real-Time
Express LD Iliac Premounted Stent System Boston Scientific
Maple Grove, MN 55311
Approval for modifications to the MRI sections of the product labeling.
P090012/S003
10/22/14
180-Day
MelaFind Mela Sciences, Inc.
Irvington, NY 10533
Approval of the post-approval study protocol.
P090026/S013
10/24/14
Real-Time
Access Hybritech P2PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the Access Substrate bottle and cap.
P100021/S039
10/23/14
Real-Time
Endurant IIs Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Approval for the addition of five (5) short bifurcated stent graft configurations to the Endurant II Stent Graft System, which are called Endurant IIs Stent Grafts (also referred to as Endurant IIs). The device, as modified, will be marketed under the trade name Endurant IIs Stent Graft System. The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of bifurcated stent graft. The Endurant II/Endurant IIs stent graft system is indicated for use in patients with the following characteristics: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, devices or accessories; 2) Proximal neck length ≥10 mm; 3) Infrarenal neck angulation ≤60°; 4) Aortic neck diameters with a range of 19 to 32 mm; 5) Distal fixation lengths ≥15 mm; 6) Iliac diameters with a range of 8 to 25 mm; and 7) Morphology suitable for aneurysm repair.
P100023/S098
10/10/14
135-Day
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a software upgrade to update the radio frequency identification (RFID) reading software.
P100028/S004
10/8/14
180-Day
Formula™ Balloon-Expandable Renal Stent System Cook Inc.
Bloomington, IN 47404
Approval for a labeling update based on the post-approval study results.
P100046/S005
10/22/14
180-Day
Atricure Synergy Ablation System Atricure, Inc.
West Chester, OH 45069
Approval for a manufacturing site located at Stellartech Research Corporation, Milpitas, California.
P100047/S049
10/16/14
180-Day
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Approval for changing the heat seal adhesive coating on the Inner and Outer Trays of the Implant Kit/ Implant Accessories and Surgical Tools.
P110010/S085
10/10/14
135-Day
PROMUS Element Plus™ Everolimus-Eluting Platinum Chromium
Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a software upgrade to update the radio frequency identification (RFID) reading software.
P110013/S044
10/16/14
180-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Approval of the post-approval study protocol.
P110019/S066
10/3/14
Panel-Track
XIENCE PRIMETM® and XIENCE PRIME LLEverolimus Eluting Coronary Stent System, XIENCE Xpedition®, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System and XIENCE AlpineTM Everolimus Eluting Coronary Stent System Abbott Vascular, Inc.
Santa Clara, CA 95054
Approval for the expansion of the indications for use of the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System to include de novo total coronary occlusions.. These devices are indicated for the following: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System The XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 28mm) with reference vessel diameters of 2.25mm to 4.25mm. Additionally, the XIENCE V stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System.  The XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE PRIME stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System The XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Alpine Everolimus Eluting Coronary Stent System.  The XIENCE Alpine Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm. Additionally, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions.
P110023/S007
10/10/14
Panel-Track
EverFlex™ Self-Expanding Peripheral Stent System ev3, Inc.
Plymouth, MN 55441
Approval for the EverFlex™ Self-Expanding Peripheral Stent System. This device is indicated for improving luminal diameter in patients with atherosclerotic disease in the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4.5 – 7.5 mm.
P110028/S012
10/3/14
135-Day
Absolute Pro Vascular Self-Expanding Stent System Abbott Vascular
Santa Clara, CA 95054
Approval for a change in the stent expansion process for the Absolute Pro Vascular Self-Expanding Stent System.
P120005/S009
10/17/14
180-Day
Dexcom SHARE System Dexcom, Inc.
San Diego, CA 92121
Approval for the Dexcom SHARE System as an optional accessory of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. The Dexcom SHARE System is manufactured at Leadtek Research Inc. in Taiwan, China.
P120005/S018
10/21/14
Panel-Track
Dexcom G4 PLATINUM Continuous Glucose Monitoring System DEXCOM, Inc.
San Diego, CA 92121
Approval for the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. This device is indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time.
P120005/S026
10/9/14
Real-Time
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Approval for a new Internet-based Software Update Tool.
P120010/S023
10/2/14
135-Day
MiniMed 530G System Medtronic Minimed Northridge, CA 91325 Approval for a change to replace the current holder (blue test plug) used as a production aid during sub-assembly manufacturing of the MiniLink (MMT-7703) and iPro2 (MMT-7741) transmitters to two new holders. The MiniLink transmitter is a component of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time and MiniMed 530G Systems. The iPro2 transmitter is a component of the iPro2 Professional Continuous Glucose Monitoring System.
P120010/S033
10/8/14
135-Day
MiniMed 530G System Medtronic Minimed
Northridge, CA 91325
Approval for a change to a supplier’s production line for a motor part of the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723 and MMT-723K) and the MiniMed 530G Insulin Pumps (models MMT-551 and MMT-751). The insulin pumps are components of the Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, and the MiniMed 530G System respectively.
P120016/S002
10/7/14
Real-Time
VASCADE™ Vascular Closure System (VCS) Cardiva Medical, Inc.
Sunnyvale, CA 94085
Approval for the addition of colorant in the push rod component of the VASCADE Vascular Closure System.
P120020/S002
10/20/14
180-Day
IDEV-SUPERA Peripheral Stent System (SFA and Proximal Popliteal) Abbott Vascular
Santa Barbara, CA 95054
Approval of the post-approval study protocol.
P130004/S001
10/2/14
180-Day
ReSure Sealant Ocular Therapeutics, Inc.
Bedford, MA
01730
Approval of the post-approval study protocol.
P130005/S001
10/29/14
Special
Diamondback 360® Coronary Orbital Atherectomy System Cardiovascular Systems, Inc.
Saint Paul, MN 55112
Approval for changes to the Instructions for Use to enhance the safety of the device or use of the device.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N16837/S018
10/2/14
Artegraft Collagen Vascular Graft Artegraft, Inc.
North Brunswick, NJ
08902
Alternate supplier of a critical process component.
N16895/S096
10/2/14
Bausch & Lomb® SofLens® (polymacon) Visibility Tinted Contact Lens Bausch & Lomb, Inc.
Rochester, NY
14609
Addition of an alternate autoclave for terminally sterilizing SofLens® contact lenses.
P810006/S055
10/16/14
Collastat Absorbable Collagen Hemostatic Sponge,
Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of a new quality control test method.
P810006/S056
10/22/14
Collastat Absorbable Collagen Hemostatic Sponge,
Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of an updated quality control test method.
P810031/S051
10/8/14
Sodium Hyaluronate Ophthalmic Visoelastic Devices (OVD), Healon®, Healon GV®, and Healon5® Products, Healon Ultimate Dual Pack and Healon Duet Dual Pack Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Replacement of the quality control sodium chloride test with an osmolality test in the manufacturing of Healon® products.
P830055/S149
10/8/14
LCS Total Knee System Depuy Orthopaedics, Inc.
Warsaw, IN
46581
New ZEISS DURAMAX CMM inspection equipment for the Atture PS RP Inserts
P830055/S151
10/10/14
LCS Total Knee System Depuy Orthopaedics, Inc.
Warsaw, IN
46581
Addition of a 2D barcode and additional scanning steps
P830061/S116
10/21/14
CapSure Sense Lead Medtronic, Inc.
Mounds View, MN 55112
Use of a new Equipment Controller Fixture to communicate the label type and label content.
P830061/S117
10/21/14
VITATRON EXCELLENCE PS+ LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P840001/S282
10/8/14
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION Medtronic, Inc.
Minneapolis, MN
55432
Implementation an electronic continuous monitoring system in the manufacturing areas.
P840001/S283
10/3/14
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION Medtronic, Inc.
Minneapolis, MN
55432
Add a sterilization system at the Sullivan Lake facility.
P840001/S284
10/16/14
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION Medtronic, Inc.
Minneapolis, MN
55432
Update the software - FACTORY WORKS RELEASE 7.11 used at several manufacturing facilities.
P840001/S285
10/16/14
RestoreUltra® Neurostimulator, RestoreAdvanced® Neurostimulator,
RestoreSensor® Neurostimulator,
RestoreUltra® SureScan® MRI Rechargeable Neurostimulator,
RestoreAdvanced® SureScan® MRI Rechargeable Neurostimulator,
RestoreSensor® SureScan® MRI Rechargeable Neurostimulator
Medtronic, Inc.
Minneapolis, MN
55432
Several changes to the inspection methods for the battery and battery subcomponents.
P840062/S042
10/16/14
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound
Dressings for Dental Surgery
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of a new quality control test method.
P840062/S043
10/22/14
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound
Dressings for Dental Surgery
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of an updated quality control test method.
P840064/S057
10/29/14
Viscoat® Ophthalmic, Viscosurgical Device, Duovisc® Ophthalmic Viscosurgical Device, Discovisc® Ophthalmic Viscosurgical Device, Provisc® Ophthalmic Viscosurgical Device (latex-free packaging configuration only) Alcon Laboratories
Fort Worth, TX 76134
Alternate contract Ethylene Oxide Sterilization vendor for PROVISC®, VISCOAT®, DUOVISC®, and DISCOVISC® Ophthalmic Viscosurgical Devices.
P850010/S055
10/16/14
Helistat, Helitene Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of a new quality control test method.
P850010/S056
10/22/14
Helistat, Helitene Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of an updated quality control test method.
P850068/S012
10/17/14
Silsoft® (elastofilcon A) Contact Lenses Bausch & Lomb
Rochester, NY 14609
Additional autoclave for the Silsoft® (elastofilcon A) contact lenses.
P850089/S112
10/21/14
CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P860004/S212
10/8/14
SYNCHROMED INFUSION SYSTEM Medtronic, Inc.
Minneapolis, MN
55432
Implementation an electronic continuous monitoring system in the manufacturing areas.
P860004/213
10/3/14
SYNCHROMED INFUSION SYSTEM Medtronic, Inc.
Minneapolis, MN
55432
Add a sterilization system at the Sullivan Lake facility.
P860004/S214
10/16/14
SYNCHROMED INFUSION SYSTEM Medtronic, Inc.
Minneapolis, MN
55432
IMPLENTATION OF THE VARSALA CONT. MONTORING SYS IMPLEMENTATION FOR MANUFACTURING AREAS AT THE SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES
P860004/S215
10/17/14
SynchroMed Infusion System Medtronic, Inc.
Minneapolis, MN 55432
Manufacturing changes to the Anchor Dispenser Tool (ADT) used during the manufacturing process.
P860057/S128
10/2/14
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprostheses Edwards Lifesciences, LLC
Irvine, CA
92614
Change from porcine to bovine tissue in the post-sterilization testing.
P890003/S322
10/21/14
VITATRON BRILLIAN S+ VDD LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P890003/S323
10/16/14
Prodigy IPG Medtronic, Inc.
Mounds View, MN 55112
Software update for the Universal Burn-In Test System (UBITS).
P890003/S324
10/23/14
Prodigy IPG Medtronic, Inc.
Mounds View, MN 55112
Reduction in the weld monitoring frequency of the battery.
P890047/S044
10/29/14
Viscoat® Ophthalmic, Viscosurgical Device, Duovisc® Ophthalmic Viscosurgical Device, Discovisc® Ophthalmic Viscosurgical Device, Provisc® Ophthalmic Viscosurgical Device (latex-free packaging configuration only) Alcon Laboratories
Fort Worth, TX 76134
Alternate contract Ethylene Oxide Sterilization vendor for PROVISC®, VISCOAT®, DUOVISC®, and DISCOVISC® Ophthalmic Viscosurgical Devices.
P900033/S038
10/16/14
Integra Dermal Regeneration Template Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of a new quality control test method.
P900033/S039
10/22/14
Integra Dermal Regeneration Template Integra LifeSciences Corporation
Plainsboro, NJ 08536
Use of an updated quality control test method.
P900033/S040
10/28/14
Integra Dermal Regeneration Template Integra LifeSciences Corporation
Plainsboro, NJ 08536
Qualification of a new shipping container for collagen products.
P900061/S132
10/30/14
EPICARDIAL PATCH LEAD, ACE Header Medtronic, Inc
Mounds View, MN 55112
Replace the manual recording system for monitoring temperature, humidity and analog gauges for monitoring differential pressure with an automated monitoring system.
P910023/S345
10/21/14
Current DR, Current DR RF, Current
Accel DR, Current+ DR, Current VR, Current VR RF, Current Accel VR, Current+ VR,
Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR
St. Jude Medical, Sylmar, CA
91342
Alternate supplier for the high voltage (HV) RF Modules utilized in the devices only.
P920015/S141
10/2/14
TRANSVENOUS,
STEROID ELUTING,
QUADRIPOLAR,
ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD-Tunneling Tool
Medtronic, Inc.
Mounds View, MN 55112
Implementation of a continuous monitoring system at the Sullivan Lake Manufacturing facility.
P920015/S142
10/7/14
TRANSVENOUS,
STEROID ELUTING,
QUADRIPOLAR,
ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD-Tunneling Tool
Medtronic CRDM
Mounds View, MN 55112
Addition of new Ethylene Oxide (EO) Sterilizer System for the device.
P920015/S143
10/10/14
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN 55112
Outsource the supply of three molded components used in the manufacture of the lead models.
P920015/S144
10/21/14
HV SPLITTER/ ADAPTOR KIT, SPRINT QUATTRO LEAD,
SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD
Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P920015/S145
10/30/14
TRANSVENOUS,
STEROID ELUTING,
QUADRIPOLAR,
ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD-Tunneling Tool
Medtronic, Inc
Mounds View, MN 55112
Replace the manual recording system for monitoring temperature, humidity and analog gauges for monitoring differential pressure with an automated monitoring system.
P920047/S074
10/21/14
Blazer II, Blazer II HTD (Blazer II), Blazer Prime HTD Boston Scientific Corporation
San Jose, CA
95134
Change to the welding equipment for the handle assembly of the Blazer family of catheters.
P930014/S075
10/21/14
AcrySof® Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX 76134
Modified/ shortened curing cycle for use in the manufacturing of AcrySof® Intraocular Lenses.
P930039/S119
10/14/14
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, and Vitatron Crystalline Active Fixation Lead Medtronic, Inc.
Mounds View, MN 55112
Outsource the supply of three molded components used in the manufacture of the lead models.
P930039/S120
10/21/14
CapSureFix Novus Lead Medtronic, Inc.
Mounds View, MN 55112
Use of a new Equipment Controller Fixture to communicate the label type and label content.
P930039/S121
10/21/14
SUREFIX LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P950005/S053
10/21/14
Celsius Electrophysiology Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of a qualified supplier for the extrusion and braiding processes of the catheter in the devices.
P950022/S087
10/27/14
Durata Family Of High Voltage Leads St. Jude Medical, Inc.
Sunnyvale, CA 94085
Add an alternate air stringing process for the cables used in the leads.
P950037/S140
10/10/14
Selox ST/JT, Setrox S, Dextrus, Tilda JT/T/R, Solox SLX, and Safio S implantable pacemaker lead families Biotronik, Inc.
Lake Oswego, OR  97035
Use of supplemental sterilization equipment.
P950037/S141
10/21/14
Entovis, Evia, Estella, Effecta and Ecuro families of implantable pulse generators, Dextrus, Setrox, Selox, TILDA, P-KIT, Safio and SLX Pacemaker Electrodes, Cardio Messenger LLT Kit BIOTRONIK, Inc.
Lake Oswego, OR 97035
Change to the labeling software which is used to print labels for the devices.
P960009/S205
10/8/14
DBS Accessories, DBS Extensions, DBS Screening Systems Medtronic, Inc.
Minneapolis, MN
55432
Implementation an electronic continuous monitoring system in the manufacturing areas.
P960009/S206
10/3/14
DBS Accessories, DBS Extensions, DBS Screening Systems Medtronic, Inc.
Minneapolis, MN
55432
Add a sterilization system at the Sullivan Lake facility.
P960009/S207
10/16/14
Activa® RC Neurotranstimulator Medtronic, Inc.
Minneapolis, MN
55432
Several changes to the inspection methods for the battery and battery subcomponents.
P960009/S208
10/16/14
DBS Accessories,
DBS Extensions,
DBS Leads,  DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Kinetra Family, Neurostimulators Soletra Family,
DBS Programming Systems, DBS Recharging Systems, DBS Screening Systems
Medtronic, Inc.
Minneapolis, MN
55432
Update the software (use of FACTORY WORKS release 7.11) used at several manufacturing facilities.
P960009/S209
10/17/14
Deep Brain Stimulation (DBS) INS Activa Family Medtronic Neurostimulation
Minneapolis, MN 55432
Changes to the Lead Cap inspection process.
P960040/S333
10/16/14
DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4, INCEPTA, ENERGEN, and PUNCTUA Cardiac Resynchronization Therapy-Defibrillators
(CRT-Ds)
Boston Scientific
St. Paul, MN
55112
Vertically integrate the manufacture of the spring contacts used in the header components of the devices.
P960040/S334
10/20/14
DYNAGEN™ ICD,
INOGEN™ ICD, ORIGEN™ ICD
Boston Scientific Corporation
St. Paul, MN
55112
Manufacture the feedthru rivets of the HV capacitor internally for the devices rather than purchasing from a supplier.
P960040/S335
10/28/14
DYNAGEN ™ ICD, INOGEN ™ ICD, ORIGEN ™ ICD Boston Scientific Corporation
St. Paul, MN
55112
Change in the supplier’s manufacturing process for the backfill hole in the High Voltage Capacitor Cans (HV Cap).
P960042/S050
10/30/14
Spectranetics Laser Sheath SLS Spectranetics Corp.
Colorado Springs, CO
80921
Change in the optical fiber incoming sampling plan.
P970004/S183
10/8/14
SNS Urinary Accessories, SNS Urinary Extensions, SNS Urinary Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN
55432
Implementation an electronic continuous monitoring system in the manufacturing areas.
P970004/S184
10/3/14
SNS Urinary Accessories, SNS Urinary Extensions, SNS Urinary Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN
55432
Add a sterilization system at the Sullivan Lake facility.
P970004/S185
10/16/14
SNS Urinary Accessories, SNS Urinary Extensions, SNS Urinary Leads,
SNS Urinary Neurostimulator Implantable InterStim Family,
SNS Urinary Programming Systems, SNS Urinary Screening Trialing Systems (including Temporary Lead)
Medtronic, Inc.
Minneapolis, MN
55432
Update the software (FACTORY WORKS release 7.11) used at several manufacturing facilities.
P980003/S054
10/28/14
Chilli II Cooled Ablation Catheter Boston Scientific Corp.
San Jose, CA
95134
Change for a component of the polyurethane adhesive used for Chilli II catheters.
P980006/S023
10/15/14
PureVision® (balafilcon A) Product Family Bausch & Lomb
Rochester, NY 14609
Additional vendor for a raw material (monomer) in the PureVision® (balafilcon A) product family.
P980016/S504
10/3/14
Evera S DR ICD,
Evera S VR ICD,
Evera XT DR ICD,
Evera XT VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Reduction in the frequency of weld monitoring.
P980016/S505
10/16/14
EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR,
MAXIMO II, PROTECTA, PROTECTA XT, SECURA, and VIRTUOSO II DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Medtronic, Inc.
Mounds View, MN 55112
Updates to the distribution center sorter tool system.
P980016/S506
10/17/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD,  Evera XT VR ICD Medtronic, Inc.
Mounds View, MN 55112
New press crimp equipment and process for the  devices.
P980016/S507
10/16/14
Evera S DR ICD,
Evera S VR ICD,
Evera XT DR ICD,
Evera XT VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Software update for the Universal Burn-In Test System (UBITS).
P980016/S508
10/23/14
Maximo II, Protecta, Protecta XT, Secura, and Virtuoso II Families of ICD’s Medtronic, Inc.
Mounds View, MN 55112
Reduction in the weld monitoring frequency of the battery.
P980023/S061
10/10/14
Linoxsmart S/SD/T/TD, Linoxsmart S DX, Vigila, Volta 1CR/1CT/2CR/2CT, Kainox VCS, Protego S/SD/T/TD Implantable Defibrillator Lead Families Biotronik, Inc.
Lake Oswego, OR  97035
Use of supplemental sterilization equipment.
P980023/S062
10/21/14
Kainox VCS, Linoxsmart, D2-KIT, VIGILA, VOLTA and Protego Permanent Defibrillator Electrodes BIOTRONIK, Inc.
Lake Oswego, OR 97035
Change to the labeling software which is used to print labels for the devices.
P980035/S395
10/16/14
ADAPTA, VERSA, SENSIA, ADVISA DR, ADVISA DR MRI, and
RELIA IMPLANTABLE PULSE GENERATORS
Medtronic, Inc.
Mounds View, MN 55112
Updates to the distribution center sorter tool system.
P980035/S396
10/16/14
Adapta, Versa, Sensia IPG Advisa DR IPG, Advisa DR MRI IPG, Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Software update for the Universal Burn-In Test System (UBITS).
P980035/S397
10/30/14
Adapta, Versa, Sensia IPG, Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Addition of a new hybrid tester platform.
P980035/S398
10/23/14
Adapta, Versa, and Sensia Families of IPG Medtronic, Inc.
Mounds View, MN 55112
Reduction in the weld monitoring frequency of the battery.
P980040/S050
10/23/14
TECNIS® 1-Piece Lens, TECNIS® Multifocal 1-Piece Lens, SENSAR® 1-Piece IOL, TECNIS® Multifocal 1-Piece Lens and TECNIS® 1-Piece Lens Abbott Medical Optics Inc.
Santa Ana, CA 92705
Add a new oil-free compressed air (OFCA) system at the AMO Anasco, Puerto Rico facility.
P990025/S041
10/21/14
Navistar RMT Electrophysiology Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of a qualified supplier for the extrusion and braiding processes of the catheter in the devices.
P990034/S033
10/16/14
ISOMED PUMP AND INFUSION SYSTEM Medtronic, Inc.
Minneapolis, MN
55432
Update the software (FACTORY WORKS RELEASE 7.11) used at several manufacturing facilities.
P990074/S032
10/29/14
Natrelle Saline Filled Breast Implants Allergan Medical
Goleta, CA
93117
Change in the bioburden testing method and samples used for testing.
P990075/S027
10/29/14
Mentor SPECTRUM and Saline-Filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA  93111
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
P000009/S059
10/21/14
ICS 3000/Renamic Programmers BIOTRONIK, Inc.
Lake Oswego, OR 97035
Change to the labeling software which is used to print labels for the devices.
P000029/S079
10/10/14
Deflux Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Change the environmental limits of the clean rooms at the firm.
P000037/S038
10/10/14
On-X Prosthetic Heart Valve On-X Life Technologies, Inc.
Austin, TX
78752
Change to the software used for the Prooftester equipment.
P000040/S033
10/21/14
Genesys HTA System Boston Scientific Corporation
Marlborough, MA 01752
Remove redundant inspections.
P010012/S372
10/16/14
ORIGEN EL, INOGEN EL, DYNAGEN EL, ORIGEN MINI, INOGEN MINI, DYNAGEN MINI, INCEPTA, ENERGEN, and PUNCTUA Implantable Cardioverter Defibrillators (ICDs) Boston Scientific
St. Paul, MN
55112
Vertically integrate the manufacture of the spring contacts used in the header components of the devices.
P010012/S373
10/20/14
DYNAGEN™, INOGEN™ CRT-D,
ORIGEN™ CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Manufacture the feedthru rivets of the HV capacitor internally for the devices rather than purchasing from a supplier.
P010012/S374
10/28/14
DYNAGEN ™ CRT-D, INOGEN™ CRT-D, ORIGEN™ CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Change in the supplier’s manufacturing process for the backfill hole in the High Voltage Capacitor Cans (HV Cap).
P010012/S375
10/22/14
EASYTRAK 2 LVA Dual Electrode LV-1 Passive, EASYTRAK 2 LVA Dual Electrode IS-1 Passive Boston Scientific Corporation
St. Paul, MN
55112
Update the proximal electrode laser welding parameters for welding the proximal electrode to the lead coil.
P010013/S060
10/6/14
NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA
01752
Update on manufacturing procedure to reduce scrap at the work station.
P010015/S251
10/16/14
CONSULTA, SYNCRA, and VIVA CRT-PACEMAKERS Medtronic, Inc.
Mounds View, MN 55112
Updates to the distribution center sorter tool system.
P010015/S252
10/21/14
ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P010015/S253
10/16/14
Consulta CRT-P,
Syncra CRT-P,
Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Software update for the Universal Burn-In Test System (UBITS).
P010031/S468
10/3/14
Brava CRT-D,
Brava Quad CRT-D, Viva Quad S
CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Reduction in the frequency of weld monitoring.
P010031/S469
10/16/14
BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II,
PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, and VIVA XT CRT-DEFIBRILLATORS
Medtronic, Inc.
Mounds View, MN 55112
Updates to the distribution center sorter tool system.
P010031/S470
10/17/14
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
New press crimp equipment and process for the  devices.
P010031/S471
10/16/14
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-, Viva Quad XT CRT-D,
Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Software update for the Universal Burn-In Test System (UBITS).
P010031/S472
10/23/14
Concerto II, Consulta, Maximo II, Protecta, and Protecta XT Families of CRT-D’s Medtronic, Inc.
Mounds View, MN 55112
Reduction in the weld monitoring frequency of the battery.
P010032/S084
10/6/14
Eon Mini Neuromodulation Systems St. Jude Medical
Plano, TX
75024
Add manufacturing process changes to the cutting methods, and change in the frequency of lubricant dispensing.
P010068/S042
10/21/14
Navistar RMT DS Electrophysiology Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of a qualified supplier for the extrusion and braiding processes of the catheter in the devices.
P020004/S104
10/16/14
Gore Excluder AAA Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Implementing a surface treatment process for the packaging mandrels used in the Gore Excluder AAA Endoprosthesis.
P020004/S105
10/17/14
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of a new coating on a manufacturing aid mandrel.
P020004/S106
10/29/14
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing.
P020004/S108
10/29/14
Excluder AAA Endoprosthesis W.L. Gore &
Flagstaff, AZ
86004
Duplicate the sewing capability for catheter component manufacturing from the Flagstaff facility at the Phoenix facility.
P020004/S109
10/29/14
Excluder AAA Endoprosthesis W.L. Gore &
Flagstaff, AZ
86003
Duplicate the stent winding process and new tempering ovens at the Sunnyvale facility.
P020009/S126
10/16/14
Express2™ Monorail® and OTW Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Change to the carrier tube manufacturing process.
P020018/S053
10/21/14
Zenith Flex AAA Endovascular Graft,
Zenith Renu AAA Ancillary Graft,
Zenith Fenestrated AAA Endovascular Graft
Cook Inc.
Bloomington, IN 47402
Alternate method to seal the stent graft fabric edges.
P020025/S064
10/21/14
Blazer II XP (Blazer II XP), Blazer Prime XP Boston Scientific Corporation
San Jose, CA
95134
Change to the welding equipment for the handle assembly of the Blazer family of catheters.
P020036/S030
10/23/14
Cordis® SMART® and SMART® Control® Nitinol Stent Systems Cordis Corporation
Fremont, CA 94555
Changes to optimize the pouch sealing process as well as a new pouch sealer.
P020045/S062
10/1/14
Freezor Cardiac CryoAblation System Medtronic AF Solutions
Mounds View, MN 55112
Alternate supplier to Medtronic CryoCath for the electrical cable subassemblies for the Arctic Front Advance/Freezor and the Electrical Umbilical Cable.
P020045/S063
10/15/14
Freezor Cardiac CryoAblation Catheter,
Freezor Xtra Surgical Cardiac CryoAblation Device,
Freezor Max Surgical Cardiac CryoAblation Device,
Medtronic CryoCath
Quebec, Canada H9R 5Z8
Changes to packaging/labeling systems used to trigger label printing and facilitate selection of product determination for packaging.
P020047/S059
10/9/14
ML8 Coronary Stent Systems Abbott Vascular
Santa Clara, CA 95054
Change to the pyrogen testing process.
P020047/S060
10/24/14
MULTI-LINK 8 Coronary Stent System Abbott Vascular
Santa Clara, CA 95054
Change to the pyrogen testing process.
P020049/S004
10/31/14
ProCol® Vascular Bioprosthesis Hancock Jaffe Laboratories, Inc.
Irvine, CA
92618
Alternate supplier for bovine veins.
P020056/S028
10/29/14
NATRELLE Silicone-Filled Breast Implants Allergan Medical
Goleta, CA
93117
Change in the bioburden testing method and samples used for testing.
P030017/204
10/9/14
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems Boston Scientific Corporation
Valencia, CA
91355
Add a supplier of cables.
P030017/S205
10/9/14
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems Boston Scientific Corporation
Valencia, CA
91355
Add a supplier of printed circuit board components.
P030022/S031
10/17/14
Reflection Ceramic Acetabular Hip System (RCHS) Smith & Nephew, Inc.
Cordova, TN
38016
New vendors.
P030031/S061
10/15/14
ThermoCool SF
(Bi-Directional and Uni-Directional) Catheters
Biosense Webster, Inc.
Diamond Bar, CA 91765
Modification of the process used to manufacture the ThermoCool SF Irrigated Tip Shell.
P030036/S075
10/21/14
SELECTSECURE LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P030047/S027
10/13/14
Cordis® PRECISE® Nitinol Stent System Cordis Corporation
Fremont, CA 94555
Changes to optimize the pouch sealing process as well as a new pouch sealer.
P030053/S020
10/29/14
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA  93111
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
P030054/S275
10/21/14
Promote, Promote Accel, Promote RF, Promote Q, Promote Quadra, Promote+, Quadra Assura, Unify, Unify Assura, Unify Quadra St. Jude Medical, Sylmar, CA
91342
Alternate supplier for the high voltage (HV) RF Modules utilized in the devices only.
P040016/S132
10/16/14
VeriFLEX™ (Liberté®) Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Change to the carrier tube manufacturing process.
P040027/S038
10/29/14
GORE® VIATORR® TIPS Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing.
P040037/S071
10/17/14
GORE® VIABAHN® Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of a new coating on a manufacturing aid mandrel.
P040037/S072
10/24/14
GORE® VIABAHN® Endoprosthesis W.L. Gore and Associates, Inc.
Flagstaff, AZ
86001
Implementation of an alternate PTFE resin raw material.
P040037/S073
10/29/14
GORE® VIABAHN® Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing.
P040043/S068
10/17/14
GORE® TAG® Thoracic Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of a new coating on a manufacturing aid mandrel.
P040043/S069
10/29/14
GORE® TAG® Thoracic Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing.
P040046/S011
10/29/14
NATRELLE Highly Cohesive Silicone-Filled Breast Implants Allergan Medical
Goleta, CA
93117
Change in the bioburden testing method and samples used for testing.
P050006/S043
10/29/14
GORE® HELEX® Septal Occluder W.L. Gore and Flagstaff, AZ
86001
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing.
P050007/S032
10/10/14
StarClose SE Vascular Closure System Abbott Vascular, Inc.
Temecula, CA
92590
Modified cleaning process for the clip subassembly.
P050023/S080
10/21/14
Ilesto, Iforia and Lumax Families of ICDs and CRT-Ds BIOTRONIK, Inc.
Lake Oswego, OR 97035
Change to the labeling software which is used to print labels for the devices.
P050042/S030
10/16/14
ARCHITECT Anti-HCV Abbott Laboratories Abbott Park, IL 60064 Addition of an alternate supplier for a material used in the manufacture of upstream assay components.
P050051/S027
10/29/14
ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL 60064
Addition of an alternate supplier for a raw material used in the manufacture of the ARCHITECT AUSAB reagent kit.
P060010/S012
10/6/14
Spanner Temporary Prostatic Stent SRS Medical Systems, Inc.
North Billerica, MA 01862
Utilization of a larger existing cleanroom within the current manufacturing facility.
P060028/S002
10/29/14
MEMORYSHAPE Breast Implants Mentor Worldwide LLC
Santa Barbara, CA  93111
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
P060035/S023
10/16/14
ARCHITECT CORE-M Abbott Laboratories Abbott Park, IL 60064 Addition of an alternate supplier for a material used in the manufacture of upstream assay components.
P060039/S064
10/21/14
ATTAIN STARFIX LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P070008/S055
10/10/14
Corox OTW/OTW-S/OTW-L and Celerity 2D/3D/ Pilot Left
Ventricular Lead Families
Biotronik, Inc.
Lake Oswego, OR  97035
Use of supplemental sterilization equipment.
P070008/S056
10/21/14
Evia, Entovis and Stratos Families of CRT-Ps. Corox OTW and CELERITY Families of Pacemaker Electrodes, LV-KIT BIOTRONIK, Inc.
Lake Oswego, OR 97035
Change to the labeling software which is used to print labels for the devices.
P070015/S124
10/9/14
XIENCE V and XIENCE nano Everolimus Eluting Coronary
Stent Systems
Abbott Vascular
Santa Clara, CA 95054
Change to the pyrogen testing process.
P070015/S125
10/22/14
XIENCE Prime® Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition® Everolimus Eluting Coronary Stent Systems, XIENCE Alpine® Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA 92591
Change to the timing of sampling for particulate testing for product release testing.
P070015/S126
10/24/14
XIENCE Prime® Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition® Everolimus Eluting Coronary Stent Systems, XIENCE Alpine® Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA 92591
Change to the pyrogen testing process.
P080006/S074
10/2/14
Attain Performa Quadripolar Lead Medtronic, Inc
Mounds View, MN 55112
Updating the final packaging line at the Villalba, Puerto Rico facility.
P080006/S075
10/30/14
Attain Performa Quadripolar Lead Medtronic, Inc
Mounds View, MN 55112
Replace the manual recording system for monitoring temperature, humidity and analog gauges for monitoring differential pressure with an automated monitoring system.
P080020/S013
10/30/14
Gel-One Seikagaku Corporation
Tokyo
Japan
100-0005
Continuation of shared manufacturing equipment for additional purposes.
P080023/S025
10/16/14
ARCHITECT CORE Abbott Laboratories Abbott Park, IL 60064 Addition of an alternate supplier for a material used in the manufacture of upstream assay components.
P080025/S079
10/8/14
SNS Bowel Accessories, SNS Bowel Extensions, SNS Bowel Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN
55432
Implementation an electronic continuous monitoring system in the manufacturing areas.
P080025/S080
10/3/14
SNS Bowel Accessories, SNS Bowel Extensions, SNS Bowel Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN
55432
Add a sterilization system at the Sullivan Lake facility.
P080025/S081
10/16/14
SNS Bowel Accessories,
SNS Bowel Extensions, SNS Bowel Leads, SNS Bowel Neurostimulators Implantable InterStim Family,
SNS Bowel Programming Systems, SNS Bowel Screening Trialing Systems (including Temporary Leads)
Medtronic, Inc.
Minneapolis, MN
55432
Update the software  (FACTORY WORKS RELEASE 7.11)used at several manufacturing facilities.
P090013/S157
10/10/14
Sprint Quattro Lead Medtronic, Inc.
Mounds View, MN 55112
Outsource the supply of three molded components used in the manufacture of the lead models.
P090013/S158
10/16/14
REVO MRI IMPLANTABLE PULSE GENERATORS Medtronic, Inc.
Mounds View, MN 55112
Updates to the distribution center sorter tool system.
P090013/S159
10/21/14
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN 55112
Use of a new Equipment Controller Fixture to communicate the label type and label content.
P090013/S160
10/21/14
CAPSUREFIX MRI LEAD Medtronic, Inc.
Mounds View, MN 55112
Transfer incoming inspections of specified components to Medtronic Puerto Rico Operations Center and Federal Express Corporation/3PL.
P090013/S161
10/16/14
Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Software update for the Universal Burn-In Test System (UBITS).
P100010/S044
10/1/14
Arctic Front CryoCatheter System Medtronic AF Solutions
Mounds View, MN 55112
Alternate supplier to Medtronic CryoCath for the electrical cable subassemblies for the Arctic Front Advance/Freezor and the Electrical Umbilical Cable.
P100010/S045
10/15/14
Freezor Max Cardiac CryoAblation Device,
Arctic Front Cardiac Cryoablation Catheter,
Arctic Front Advance Cardiac Cryoablation Catheter
Medtronic CryoCath
Quebec, Canada H9R 5Z8
Changes to packaging/labeling systems used to trigger label printing and facilitate selection of product determination for packaging.
P100014/S016
10/10/14
Solesta Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Changes to the environmental limits of the clean rooms used during Solesta manufacturing.
P100021/S040
10/3/14
Endurant & Endurant II Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
 
Addition of an alternate supplier for the secondary and tertiary packaging for Endurant and Endurant II Stent Graft Systems. Additionally, a change in configuration for the E-beam sterilization process.
P100023/S107
10/22/14
Ion™ Paclitaxel-eluting Platinum Chromium Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Implement an update to software on the Automated Catheter Manufacturing Line.
P100023/S108
10/30/14
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Elimination of a redundant in-process stent mass measurement step at the Galway and Plymouth manufacturing sites.
P100041/S058
10/2/14
SAPIEN Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Change from porcine to bovine tissue in the post-sterilization testing.
P100041/S059
10/20/14
SAPIEN® Transcatheter Heart Valve (TVH) Edwards Lifesciences LLC
Irvine, CA
92614
Implementation of an additional OD inspection to the SAPIEN® and SAPIEN XT™ Transcatheter Heart Valves, Models 9000TFX and 9300TFX.
P100047/S050
10/10/14
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014
Changes to the Process Challenge Device (PCD) used for monitoring the Ethylene Oxide sterilization cycle of the sterilized components.
P110010/S094
10/22/14
PROMUS Element™ Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Implement an update to software on the Automated Catheter Manufacturing Line.
P110010/S097
10/30/14
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Elimination of a redundant in-process stent mass measurement step at the Galway and Plymouth manufacturing sites.
P110013/S045
10/8/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA
95403
Modification to the residual solvents quality control test method.
P110014/S004
10/22/14
MarginProbe System Dune Medical, Ltd.
Caesarea Industrial Park
Israel
38900
Addition of a test jig and the replacement of the vacuum pressure regulator component.
P110019/S071
10/9/14
XIENCE PRIME and XIENCE PRIME LL Everolimus- Eluting Coronary Stent Systems and Xience Xpedition Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA 92591
Change to the pyrogen testing process.
P110019/S072
10/22/14
XIENCE V® Everolimus Eluting Coronary Stent Systems, XIENCE nano® Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA 92591
Change to the timing of sampling for particulate testing for product release testing.
P1100019/S073
10/24/14
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems, XIENCE Xpedition Everolimus Eluting Coronary Stent Systems and XIENCE Alpine Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA 92591
Change to the pyrogen testing process.
P110021/S044
10/2/14
SAPIEN Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Change from porcine to bovine tissue in the post-sterilization testing.
P110021/S045
10/20/14
SAPIEN® Transcatheter Heart Valve (TVH) Edwards Lifesciences LLC
Irvine, CA
92614
Implementation of an additional OD inspection to the SAPIEN® and SAPIEN XT™ Transcatheter Heart Valves, Models 9000TFX and 9300TFX.
P110021/S046
10/23/14
SAPIEN™ Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvine, CA
92614
Changes to the sampling plan for product verification testing of the delivery systems and accessories manufactured at the Irvine, California facility.
P110032/S009
10/28/14
Aorfix AAA Stent Graft System Lombard Medical Technologies, Inc.
Irvine, CA
92618
Use of a new cleanroom at an existing manufacturing site.
P110042/S041
10/23/14
S-ICD System Boston Scientific
Corporation
St. Paul, MN
55112
Modification to the test software for the S-ICD at E2 and E4 electrical test steps.
P110043/S008
10/9/14
Omnilink Elite Vascular Balloon-Expandable Stent System Abbott Vascular
Santa Clara, CA 95054
Change to the pyrogen testing process.
P120002/S005
10/23/14
Cordis® SMART® and SMART® Control® Vascular Stent Systems Cordis Corporation
Fremont, CA 94555
Changes to optimize the pouch sealing process as well as a new pouch sealer.
P120010/S034
10/2/14
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
New laser system be added to the sensor fabrication process for the Enlite Sensor (MMT-7708), a component of the MiniMed 530G System.
P120010/S035
10/2/14
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Modification of drawing specifications for the Sensor Patch used with the Enlite Sensor (MMT-7008) and the addition of another inspection measurement. The Enlite Sensor is a component of the MiniMed 530G System.
P120016/S006
10/23/14
Cardiva Medical VASCADE™ Vascular Closure System (VCS) Cardiva Medical, Inc.
Sunnyvale, CA 94085
Reorganization of two existing manufacturing steps and a change of location of the processes to be performed to outside of a Controlled Environment Room (CER).
P130004/S005
10/10/14
RESURE® SEALANT Ocular Therapeutix, Inc.
Bedford, MA
01730
Critical Supplier Location Change- Additional Facility for JenKem, Technology.
P130006/S011
10/17/14
GORE® VIABAHN® Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of a new coating on a manufacturing aid mandrel.
P130006/S012
10/24/14
GORE® VIABAHN® Endoprosthesis W.L. Gore and Associates, Inc.
Flagstaff, AZ
86005
Implementation of an alternate PTFE resin raw material.
P130006/S013
10/29/14
GORE® VIABAHN® Endoprosthesis W.L. Gore and Flagstaff, AZ
86001
Implementation of an alternate Gore facility to conduct cytotoxicity testing and a new tube reader for LAL bacterial endotoxin testing.
P130009/S011
10/2/14
SAPIEN XT™ Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Change from porcine to bovine tissue in the post-sterilization testing.
P130009/S012
10/20/14
Edwards SAPIEN XT™ Transcatheter Heart Valve (TVH) Edwards Lifesciences LLC
Irvine, CA
92614
Implementation of an additional OD inspection to the SAPIEN® and SAPIEN XT™ Transcatheter Heart Valves, Models 9000TFX and 9300TFX.
P130009/S013
10/23/14
SAPIEN XT™ Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvine, CA
92614
Changes to the sampling plan for product verification testing of the delivery systems and accessories manufactured at the Irvine, California facility.
P130009/S014
10/24/14
SAPIEN XT™ Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvine, CA
92614
Change to the testing requirements for the crimp and expansion test for the valve frames.
P130021/S007
10/10/14
Medtronic CoreValve System Medtronic CoreValve, LLC
Santa Rosa, CA
95403
Expand the capacity of the clean room used to perform the tissue processing steps for the CoreValve Transcatheter Aortic Valve at the Medtronic Mexico facility.
P130030/S004
10/21/14
REBEL Platinum Chromium Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Eliminate burst, diameter, and distension in-process monitoring requirements from the balloon component manufacturing process.
P130030/S005
10/22/14
REBEL™ Platinum Chromium Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Implement an update to software on the Automated Catheter Manufacturing Line.
P130030/S006
10/30/14
Rebel Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Elimination of a redundant in-process stent mass measurement step at the Galway and Plymouth manufacturing sites.

Summary of PMA Originals & Supplements Approved

  • Originals: 2
  • Supplements: 87

Summary of PMA Originals Under Review

  • Total Under Review: 54
  • Total Active: 24
  • Total On Hold: 30

Summary of PMA Supplements Under Review

  • Total Under Review: 466
  • Total Active: 340
  • Total On Hold: 126

Summary of All PMA Submissions

  • Originals: 3
  • Supplements: 67

Summary of PMA Supplement PMA Approval/Denial Decision Times

  • Number of Approvals: 87
  • Number of Denials: 0
  • Average Days Fr Receipt to Decision (Total Time): 173.2
  • FDA Time: 127.2 Days
  • MFR Time: 46.0 Days

Page Last Updated: 01/26/2016
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