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U.S. Department of Health and Human Services

Medical Devices

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June 2012 PMA Approvals

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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
P080030
6/25/12
Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-l00i) Glaukos Corporation
Laguna Hills, CA
92653
Approval for the Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and inserter (GTS-l00i). This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.
P090026
6/14/12
Access® Hybritech® p2PSA on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the Access® Hybritech® p2PSA on the Access Immunoassay Systems. This device is indicated for: The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Access Hybritech p2PSA is intended to be used in combination with Access Hybritech (total) PSA and Access Hybritech free PSA to calculate the Beckman Coulter Prostate Health Index (phi), an In Vitro Diagnostic Multivariate Index Assay (IVDMIA).
Beckman Coulter phi as calculated using the Access Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsyis required for diagnosis of cancer.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810025/S027
6/14/12
180-Day
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD) Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for a manufacturing site change and change in terminal sterilization method (i.e., E-beam to Vapor Hydrogen Peroxide) of the product.
P860008/S021
6/5/12
135-Day
TAPSCOPE 550 CardioCommand, Inc.
Tampa, FL
33607
Approval of a new supplier for the molding of the pacing wire connector and revision to the manufacturing process of the pacing wire assembly.
P890003/S247
6/4/12
180-Day
DDMA Software Medtronic, Inc.
Mounds View, MN
55112
Approval for DDMA Software Model 2491.
P890055/S040
6/25/12
Real-Time
MedStream Programmable Infusion System Codman & Shurtleff, Inc.
Raynham, MA
02767
Approval for software modifications to the Programmable
Infusion System. These modifications were data integrity check improvement, resolution of
Control Unit keyboard, frame check sequence algorithm upgrade, software anomalies 015, 016, 017, 020 fix, and improvement of the Bridge Bolus, Priming Bolus and Single Bolus
processes.
P900023/S052
6/26/12
180-Day
Ipulse™ Circulatory Support System Abiomed, Inc.
Danvers, MA
09123
Approval for correction of the AB5000 Driver Failure Notification alarm, addition of a delay circuit to the external AB Portable Power Supply, and correction to the Ipulse Driver Plenum Seal.
P910077/S121
6/19/12
Real-Time
LATTIUDE Communicator Boston Scientific Corporation
St. Paul, MN
55112
Approval for the addition of the option to connect the LATTITUDE Communicator to an off-the-shelf commercially available cellular modem.
P930014/S058
6/7/12
180-Day
Acrysof® Toric and Acrysof® IQ Toric High Cylinder Power IOLs Alcon Research, Ltd.
Fort Worth, TX
76134
Approval of the post-approval study protocol.
P950022/S081
6/28/12
135-Day
Durata Family of Leads St. Jude Medical
Sylmar, CA
91342
Approval for implementation of a new automated tester.
P960040/S078
6/22/12
Special
VENTAK AV AICD Families Boston Scientific Corporation
St. Paul, MN
55112
Approval for the minor manufacture changes of the devices.
P960040/S261
6/19/12
Real-Time
PUNCTUA ICD, ENERGEN ICD and INCEPTA ICD Boston Scientific Corporation
St. Paul, MN
55112
Approval for modifying the design specifications for the spot weld anchor post used in ICD and CRT-D Pulse Generator (PG) headers and the leaf spring housing block used in the LV-1 for CRT-D Pulse Generator headers.
P960058/S095
6/15/12
180-Day
HiResolution Bionic Ear System Advanced Bionics, LLC
Sylmar, CA
91342
Approval for a manufacturing site located at Advanced Bionics, LLC and a finished goods warehouse located in Valencia, California.
P980016/S343
6/4/12
180-Day
Maximo II ICD, Secura ICD, and Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
Approval for Maximo II ICD Models D264DRM, D284DRG, D284VRC; Secura ICD Models D204DRM, D224DRG, D224VRC; and Virtuoso II DR/VR ICD Models D274DRG and D274VRC.
P980018/S015
6/8/12
180-Day
HercepTest™ Dako Denmark A/S
Glostrup, Denmark DK-2600
Approval for addition of pertuzumab in the labeling of HercepTest™. The
device, as modified, will be marketed under the trade name HercepTest™ and its indication for
use is: “HercepTest™ is a semi-quantitative immunohisto-chemical assay to determine HER2
protein overexpression in breast cancer tissues routinely processed for histological evaluation and
formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or
gastroesophageal junction adenocarcinoma. HercepTest™ is indicated as an aid in the assessment
of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being
considered and for breast cancer patients for whom PERJETA™ (pertuzumab) treatment is being
considered (see Herceptin® and PERJETA™ package inserts)."
P980022/S103
6/19/12
135-Day
Medtronic MiniMed Continuous Glucose Monitoring System,
Paradigm REAL-Time System,
Guardian REAL-Time System,
CGMS iPro System,
CGMS iPro2 System
Medtronic, Inc.
Northridge, CA
91325
Approval for a manufacturing process change to incorporate the
addition of process water to a used batch of platinum plating solution for the Sof Sensor Glucose
Sensors (models MMT-7002 and MMT-7003) that are components of the Medtronic MiniMed
Continuous Glucose Monitoring System, the Paradigm REAL-Time System, the Guardian REAL-Time System, the CGMS iPro System and the CGMS iPro2 System.
P980035/S264
6/4/12
180-Day
Advisa DR IPG and Application Software for CareLink Programmer Medtronic, Inc.
Mounds View, MN
55112
Advisa DR IPG Model A4DR01 and Application Software Model 9995 Version 7.4 for CareLink Programmer Model 2090.
P990046/S029
6/25/12
180-Day
Open Pivot Heart Valve Medtronic, Inc.
Minneapolis, MN
55447
Approval of the post-approval study protocol.
P000012/S038
6/7/12
180-Day
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P000023/S007
6/27/12
180-Day
TMJ Fossa-Eminence and Condylar Prosthesis System TMJ Medical
Golden, CO
80401
Approval for a manufacturing site located at TMJ Medical in Golden, Colorado.
P000035/S007
6/27/12
180-Day
TMJ Fossa-Eminence and Prosthesis System TMJ Medical
Golden, CO
80401
Approval for a manufacturing site located at TMJ Medical in Golden, Colorado.
P000037/S025
6/8/12
135-Day
On-X Prosthetic Heart Valve On-X Life Technologies
Austin, TX
78752
Approval to move the machining process for size 25 valve housing substrates in-house.
P000040/S024
6/19/12
Real-Time
GeneSys HTA™ System Boston Scientific Corporation
Marlborough, MA
01752
Approval for minor changes to the electrical design of the controller.
P010012/S069
6/22/12
Special
CONTAK CD Families Boston Scientific Corporation
St. Paul, MN
55112
Approval for the minor manufacture changes of the devices.
P010012/S291
6/19/12
Real-Time
PUNCTUA CRT-D, ENERGEN CRT-D and INCEPTA CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Approval for modifying the design specifications for the spot weld anchor post used in ICD and CRT-D Pulse Generator (PG) headers and the leaf spring housing block used in the LV-1 for CRT-D Pulse Generator headers.
P010015/S157
6/4/12
180-Day
Consulta CRT-P and Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Approval for Consulta CRT-P Model C4TR01 and Syncra CRT-P Model C2TR01.
P010030/S025
6/29/12
Real-Time
LifeVest Wearable Defibrillator ZOLL LifeCor Corporation
Pittsburgh, PA
15238
Approval for design changes to the LifeVest garment including location of the rear therapy pads and vibration box, method of securing vibration box to garment, adjustment mechanism for shoulder strap, width of elastic strap and related labeling changes.
P010031/S296
6/4/12
180-Day
Concerto II CRT-D, Consulta CRT-D and Maximo II CRT-D Medtronic, Inc.
Mounds View, MN
55112
Approval for Concerto II CRT-D Model D274TRK, Consulta CRT-D Models D204TRM and D224TRK and Maximo II CRT-D Models D264TRM and D284TRK.
P010031/S0304
6/29/12
180-Day
Cardiac Resynchronization Therapy Defibrillator
(CRT-D)
Medtronic, Inc.
Mounds View, MN
55112
Approval of the post-approval study protocol
P010041/S030
6/26/12
180-Day
S.A.V. Bioprosthesis Edwards Lifesciences LLC
Irvine, CA
92614
Approval for the labeling change based on the post-approval study data.
P020011/S005
6/25/12
180-Day
VERSANT® HCV RNA Qualitative Assay and APTIMA® HCV RNA Qualitative Assay` Gen-Probe Incorporated
San Diego, CA
92121
Approval for a device name change. The device, as modified, will be marketed under the trade name VERSANT® HCV RNA Qualitative Assay and APTIMA® HCV RNA Qualitative Assay and is indicated for the detection of hepatitis C virus (HCV) RNA in human plasma (EDTA, sodium heparin, sodium citrate, and ACD) or serum.
P030011/S012
6/26/12
135-Day
Syncardia Temporary Total Artificial Heart (TAH-T) System Syncardia Systems, Inc.
Tucson, AZ
85713
Approval for relocation of a polymer manufacturing process.
P030016/S023
6/8/12
180-Day
Visian ICL™ (Implantable Collamar Lens) STAAR Surgical Company
Monrovia, CA
91016
Approval of the post-approval study protocol.
P030022/S021
6/28/12
135-Day
Reflection Ceramic Hip System Smith & Nephew, Inc.
Memphis, TN
38116
Approval for addition of an alternate site for the machining processes for R3 Acetabular Shells.
P030031/S039
6/15/12
180-Day
Thermo Cool SF Bi-Directional and Uni-Directional Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for an alternative sterilization facility located at Sterigenics US in Santa Teresa, New Mexico.
P030036/S039
6/6/12
135-Day
SelectSecure Leads Medtronic, Inc.
Mounds View, MN
55112
Approval for a new laser welder and updated weld parameters.
P040002/S037
6/1/12
Real-Time
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Approval for a modification to the SurePass contralateral limb wire subassembly.
P040005/S006
6/8/12
180-Day
HER2 FISH pharmDx™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600
Approval for addition of pertuzumab in the labeling of HER2 FISH pharmDx™
Kit. The device, as modified, will be marketed under the trade name HER2 FISH pharmDx™ Kit and its indication for use is: "a direct fluorescence in situ hybridization (FISH) assay designed to
quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or
gastroesophageal junction adenocarcinoma.
HER2 FISH pharmDx™ Kit is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer
patients for whom PERJETA™ (pertuzumab) treatment is being considered (see Herceptin® and
PERJETA™ package inserts)."
P040023/S021
6/15/12
180-Day
Duraloc Ceramic Hip Depuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval of the post-approval study protocol.
P050028/S024
6/7/12
180-Day
COBAS® TaqMan HBV Test for use with The High Pure System and COBAS® AmpliPrep/
COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P050028/S025
6/29/12
Real-Time
COBAS® TaqMan® HBV Test for use with The High Pure System and COBAS® AmpliPrep/
COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for changes to AMPLILINK Software v3.3.6.
P050037/S028
6/20/12
180-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Frankville, WI
53126
Approval for the addition of safety and effectiveness clinical data and Post-Marketing
Surveillance data from the Post Approval studies performed as a condition of
approval for the Radiesse Injectable Implant. The device, as modified, will be marketed under the
trade name Radiesse Injectable Implant and is indicated for subdermal implantation for the
correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
P050045/S004
6/1/12
135-Day
TOP2A FISH pharmaDx™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600
Approval for the manufacturing process of PNA oligomers in the device.
P050052/S031
6/20/12
180-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Frankville, WI
53126
Approval for the addition of safety and effectiveness clinical data and Post-Marketing
Surveillance data from the Post Approval studies performed as a condition of
approval for the Radiesse Injectable Implant. The device, as modified, will be marketed under the
trade name Radiesse Injectable Implant and is indicated for subdermal implantation for the
correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
P050053/S025
6/27/12
Special
InFuse Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the proposed labeling revisions related to the appearance of the reconstituted product and warning statement about use in patients suspected of having cancer at the product application site.
P060022/S012
6/18/12
180-Day
Akreos Posterior Chamber Intraocular Lens (IOL) Bausch & Lomb Inc.
Aliso Viejo, CA
92656
Approval for modifications to the primary packaging which includes an alternate plastic vial and Intraocular Lens (IOL) holder.
P060030/S025
6/7/12
180-Day
COBAS® AmpliPrep/
COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 for use with The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P060030/S026
6/29/12
Real-Time
COBAS® AmpliPrep/
COBAS® TaqMan® HCV Test and COBAS® TaqMan® HCV Test version 2.0 for use with The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for changes to AMPLILINK Software v3.3.6.
P060040/S015
6/5/12
180-Day
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for updating the HeartMate II LVAS Instructions for Use to reflect the post-approval study findings for the bridge-to-transplant indication.
P060040/S018
6/22/12
180-Day
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for the Sealed Outflow Graft Bend Relief Collar (SOBR Collar).
P060040/S021
6/5/12
Real-Time
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for the HeartMate II Universal Percutaneous Bend Relief Repair Kit.
P070004/S004
6/7/12
180-Day
Silicone Gel Breast Implants Sientra, Inc.
Santa Barbara, CA
93117
Approval of the post-approval study protocol.
P080004/S008
6/13/12
135-Day
Hoya iSpheric Intraocular Lens (IOL) Hoya Surgical Optics, Inc.
Chino Hills, CA
91709
Approval to expand intraocular lens manufacturing.
P080032/S009
6/26/12
180-Day
Alair® Bronchial Thermoplasty System Boston Scientific Corporation
Sunnyvale, CA
94089
Approval of the post-approval study protocol.
P090018/S016
6/22/12
180-Day
Esteem – Nano Sensor and Driver Envoy Medical Corporation
Saint Paul, MN
55110
Approval to add new, physically smaller, Sensor/ Driver models to the Esteem family.
P090022/S011
6/11/12
Real-Time
Softec HDO Posterior Chamber Intraocular Lens (IOL) Lenstec, Inc.
St. Petersburg, FL
33716
Approval for modifications to the optic body shape and overall
diameter of your Softec HD lens to introduce a lens with an ovoid optic and overall diameter of 12.50 mm and changes to your labeling related to the introduction of the modified lens. The device, as
modified, will be marketed under the trade name Softec HDO and is indicated for the
replacement of the human crystalline lens following phacoemulsifica- tion cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.
P100020/S003
6/7/12
180-Day
COBAS® HPV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a manufacturing site located at Roche Molecular Systems, Inc., in Somerville, New Jersey.
P100029/S013
6/29/12
Real-Time
Trifecta™ Valve St. Jude Medical
St. Paul, MN
55117
Approval for a change to the Trifecta valve stent specification to require 100% inspection for wall thickness at a new, single location - stent rail.
P100049/S001
6/22/12
180-Day
Linx Reflux Management System Torax Medical
Shoreview, MN
55126
Approval of the post-approval study protocol.
P100049/S002
6/22/12
180-Day
Linx Reflux Management System Torax Medical
Shoreview, MN
55126
Approval of the post-approval study protocol.
P110001/S003
6/26/12
180-Day
Herculink Elite Renal Stent System Abbott Vascular
Santa Clara, CA
95054
Approval for post-approval study protocol.
P110010/S001
6/1/12
Panel-Track
PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent
System (Monorail™ and Over-The-Wire)
Boston Scientific Corporation
Maple Grove, MN
55311
Approval for the PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire). This device is indicated for improving luminal diameter in
patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in
native coronary arteries ≥ 2.25 mm to ≤ 4.00 mm in diameter in lesions ≤ 34 mm in length.
P110012/S001
6/7/12
135-Day
Vysis ALK Break Apart FISH Probe Kit Abbott Molecular, Inc.
Des Plaines, IL
60018
Approval for addition of an alternate supplier for the Human Placental (HP) DNA component for the device, per design verification protocol MD17892.
P110022/S001
6/18/12
180-Day
Elecsys Anti-HBc IgM on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for manufacturing site located at Roche Diagnostics GmbH, in Mannheim, Germany.
P110025/S001
6/18/12
180-Day
Elecsys Anti-HBc IgM on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for manufacturing site located at Roche Diagnostics GmbH, in Mannheim, Germany.
P110031/S001
6/18/12
180-Day
Elecsys Anti-HBc IgM on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for manufacturing site located at Roche Diagnostics GmbH, in Mannheim, Germany.

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
P810032/S061
6/21/12
PMMA Multi-piece Posterior Chamber Lens Alcon Laboratories, Inc.
Fort Worth, TX
76134
Approval of the Monofilament Draw Line System.
P840001/S214
6/5/12
Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified sub-tier supplier for components used in patient programmers.
P840001/S215
6/8/12
Restore®, Itrel®, Synergy® and SCS Products Kitted for Distribution Convenience Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays.
P840001/S216
6/7/12
SCS Implantable Neurostimulators/
SCS Leads/SCS Accessories/
SCS Extensions/ SCS Product Kitted for Distribution Convenience
Medtronic, Inc.
Minneapolis, MN
55432
Update the software used at several Medtronic’s manufacturing facilities.
P840001/S217
6/15/12
 
SCS INS Itrel Family and SCS INS Synergy Family Medtronic Neuromodulation
Minneapolis, MN
55432
Change to automate the manual rate check (post- sterilization test) for the impacted devices.
P850079/S052
6/28/12
CooperVision Methafilcon A and B Soft Extended Wear Contact Lenses CooperVision, Incorporated
Pleasanton, CA
94588
Change in the supplier’s method of manufacturing a raw material used to produce contact lenses.
P860004/S168
6/5/12
Synchromed Drug Pumps Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified sub-tier supplier for components used in patient programmers.
P860004/S169
6/7/12
Drug Delivery Accessories/Drug Delivery Kits for Revisions/SynchroMed Implantable Infusion Pump/Drug Delivery Catheters Medtronic, Inc.
Minneapolis, MN
55432
Update the software used at several Medtronic’s manufacturing facilities.
P860004/S170
6/6/12
SynchroMed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Manufacturing change to the laser weld process for the SynchroMed II Infusion Pump, 8637.
P860004/S171
6/18/12
SynchroMed II Implantable Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Manufacturing change to the reading of the serial number on a component for the SynchroMed II Implantable Infusion Pump, Models and 8637-20 and 8637-40.
P870072/S048
6/18/12
Thoratec Ventricular Assist Device Thoratec Corporation
Pleasanton, CA
94588
Automation of the oven-drying process.
P870072/S049
6/29/12
Thoratec Ventricular Assist Device (VAD) System Thoratec Corporation
Pleasanton, CA
94588
Change in supplier for a critical component.
P890055/S041
6/28/12
MedStream Programmable Infusion System Codman & Shurtleff, Inc.
Raynham, MA
02767
Changes to the cleaning of components during manufacturing.
P900009/S033
6/6/12
EXOGEN 4000+ Ultrasound Bone Healing System Smith & Nephew, Inc.
Cordova, TN
38016
Change in supplier.
P900056/S115
6/20/12
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of two inspection steps from RotaLink Burr assembly process.
P900060/S051
6/29/12
CarboMedics Prosthetic Heart Valve Sorin Group USA Inc.
Arvada, CO
80004
Adding machining operations for a component to your Sorin Biomedica Cardio S.r.l. facility.
P910018/S016
6/19/12
Liposorber LA-15 System Kaneka Pharma America, LLC.
New York, NY
10036
 
Change in the location of a supplier’s manufacturing facility that produces components used in the manufacturing of the device.
P930014/S062
6/21/12
AcrySof Posterior Chamber Lens Alcon Laboratories, Inc.
Fort Worth, TX
76134
Approval of the Monofilament Draw Line System.
P930031/S031
6/6/12
Wallstent TIPS Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311
Removal of two in-process cleaning steps.
P940015/S026
6/22/12
Synvisc® & Synvisc-One® Genzyme Corporation
Ridgefield, NJ
07657
Addition of a new water treatment system.
P950020/S050
6/18/12
Coronary Flextome Cutting Balloon Boston Scientific Corporation
Maple Grove, MN
55311
Process change and relocation for proximal catheter marking.
P950029/S068
6/11/12
Reply SR, DR and Esprit SR, DR Sorin CRM USA, Inc.
Plymouth, MN
55441
Alternate manufacturing equipment.
P960009/S145
6/5/12
Activa Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified sub-tier supplier for components used in patient programmers.
P960009/S146
6/8/12
Activa®, Soletra® and Kinetra® Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays.
P960009/S147
6/7/12
DBS Accessories/DBS Leads/DBS Screening Systems/DBS
Extensions/DBS Implantable Neurostimulators
Medtronic, Inc.
Minneapolis, MN
55432
Update the software used at several Medtronic’s manufacturing facilities.
P960009/S148
6/15/12
DBS INS Soletra Family and DBS INS Kinetra Family Medtronic Neuromodulation
Minneapolis, MN
55432
Change to automate the manual rate check (post- sterilization test) for the impacted devices.
P960040/S260
6/4/12
Incepta ICD, Energen ICD, Punctua ICD Boston Scientific Corporation
St. Paul, MN
55112
Updates to an existing component inspection process.
P960040/S263
6/25/12
Teligen, Incepta, Energen, Punctua, Confient ICDs Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for seal plugs used in the pulse generators.
D970003/S136
6/25/12
Altrua, Advantion, Ingenio Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for seal plugs used in the pulse generators.
P970003/S149
6/20/12
VNS Therapy® System Cyberonics, Inc.
Houston, TX
77058
New routing fixture in the manufacture of the Pulse Generator Printed Circuit Board Assembly.
P970004/S134
6/5/12
InterStim Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified sub-tier supplier for components used in patient programmers.
P970004/S135
6/8/12
InterStim® Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays.
P970004/S136
6/7/12
SNS Urinary Screening Systems/SNS Urinary Accessories/ SNS Urinary InterStim Family of Implantable Neurostimulators/ SNS Urinary Leads/ SNS Urinary Extensions/SNS UrinaryAccessories Medtronic, Inc.
Minneapolis, MN
55432
Update the software used at several Medtronic’s manufacturing facilities.
P970037/S008
6/14/12
AutoDELFIA Xpress hAFP Test System PerkinElmer, Inc.
Indianapolis, IN
46236
Second alternative type of TOPO (Trioctylphosphine oxide) raw material type used in the manufacturing of the Enhancement Solution for the device.
P980016/S352
6/4/12
Maximo II DF4, Maximo II lCD, Protecta DF4, Protecta lCD,
Protecto XT DF4, Protecta XT lCD, Secura DF4, Secura lCD, Virtuoso II DR/VR lCD
Medtronic, Inc.
Mounds View, MN
55112
Incorporate plating bake test as part of the monitoring control plan performed at the supplier.
P980016/S353
6/13/12
Protecta XT VR, Protecta VR, Secura VR and Maxmio II VR DF4 ICDs Medtronic, Inc.
Mounds View, MN
55112
Align the header manufacturing processes of the Protecta XT VR (D314VRM), Protecta VR (D334VRM), Secura VR (D204VRM) and Maxmio II VR (D264VRM) DF4 ICDs with currently manufactured devices.
P980016/S354
6/11/12
Protecta XT DR/VR, Protecta DR/VR, Secura DR/VR and Maxmio II DR/VR Medtronic, Inc.
Mounds View, MN
55112
Change to the connector contact assembly pull test sample configuration.
P980016/S355
6/15/12
Protecta, Protecta DF4, Protecta XT and Protecta XT DF4 ICDs Medtronic, Inc.
Mounds View, MN
55112
Update the software on a hybrid tester used for product acceptance testing.
P980016/S356
6/19/12
Protecta ICD/DF4 ICD/XT ICD/XT DF4 ICD Medtronic, Inc.
Mounds View, MN
55112
Update to a software package used in product acceptance testing.
P980016/S358
6/25/12
Secura VR, Maximo II VR, Protecta VR, Protecta XT VR, Secura DR, Maximo II DR, Protecta DR and Protecta XT DR Medtronic, Inc.
Mounds View, MN
55112
Update to the vendor inspection of a flex component, a change to the die attach cure process and removal of parallel gap welding line testing.
P980033/S020
6/6/12
Wallstent Venous Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311
Removal of two in-process cleaning steps.
P980035/S271
6/14/11
Advisa DR IPG Medtronic, Inc.
Mounds View, MN
55112
Update the hybrid test software.
P980049/S073
6/11/12
Paradym VR, DR and Paradym RF, SR, DR Sorin CRM USA, Inc.
Plymouth, MN
55441
Alternate manufacturing equipment.
P000039/S046
6/6/12
AMPLATZER Septal and Cribriform Occluders AGA Medical Corporation
Plymouth, MN
55442
Use of different braiding equipment to reduce the potential for abrasion of Nitinol wire.
P010012/S290
6/4/12
Incepta CRT-D, Energen CRT-D, Punctua CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Updates to an existing component inspection process.
P010012/S293
6/25/12
Cognis, Incepta, Punctua, Livian CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for seal plugs used in the pulse generators.
P010015/S163
6/14/12
Consulta CRT-P and Synca CRT-P Medtronic, Inc.
Mounds View, MN
55112
Update the hybrid test software.
P010030/S033
6/22/12
LifeVest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA
15238
Additional welding equipment.
P010031/S306
6/4/12
Concerto II CRT-D, Consulta, Consulta DF4, Maximo II CRT-D,
Maximo II DF4, Protecta CRT-D, Protecta DF4, Protecta XT CRT-D
Protecta XT DF4
Medtronic, Inc.
Mounds View, MN
55112
Incorporate plating bake test as part of the monitoring control plan performed at the supplier.
P010031/S307
6/11/12
Protecta XT
CRT-D, Protecta CRT-D, Consulta CRT-D and Maximo II CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Change to the connector contact assembly pull test sample configuration.
P010031/S308
6/15/12
Protecta, Protecta DF4, Protecta XT and Protecta XT DF4 CRT-Ds Medtronic, Inc.
Mounds View, MN
55112
Update the software on a hybrid tester used for product acceptance testing.
P010031/S309
6/19/12
Protecta CRT-D/ DF4 CFT-D/XT CRT-D/XT DF4 CRT-D Medtronic, Inc.
Mounds View, MN
55112
Update to a software package used in product acceptance testing.
P010031/S311
6/25/12
Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D and Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
Update to the vendor inspection of a flex component, a change to the die attach cure process and removal of parallel gap welding line testing.
P010032/S052
6/22/12
Axxess Leads St. Jude Medical
Plano, TX
75024
Change to the Axxess Lead functional test procedure.
P020024/S036
6/6/12
AMPLATZER Duct Occluders AGA Medical Corporation
Plymouth, MN
55442
Use of different braiding equipment to reduce the potential for abrasion of Nitinol wire.
P020045/S043
6/14/12
Universal CryoConsole
Mounds View, MN
55112
Medtronic CryoCath LP
Mounds View, MN
55112
New supplier for a pressure transducer component.
P020047/S048 MULTI-LINK 8 Coronary Stent System Abbott Vascular
Temecula, CA
92591
Removal of a final product test for reliability engineering.
P030005/S084
6/25/12
Invive CRT-P Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for seal plugs used in the pulse generators.
P030017/S135
6/6/12
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Change to the welding process in the manufacturing of the device.
P030054/S222
6/20/12
Unify Quadra
CRT-D, Unify Quadra Assura
St. Jude Medical
Sylmar, CA
91342
Alternate supplier of the RF antenna module.
P040012/S045
6/21/12
Acculink Carotid Stent System Abbott Vascular
Temecula, CA
92591
Reduce the number of samples used from each lot during pyrogen testing.
P040020/S042
6/21/12
AcrySof ReSTOR Posterior Chamber Lens Alcon Laboratories, Inc.
Fort Worth, TX
76134
Approval of the Monofilament Draw Line System.
P040023/S022
6/15/12
Duraloc Option Ceramic Hip System DePuy Orthopaedics Inc.
Warsaw, IN
46581
Changes to the device sterile packaging.
P040038/S025
6/21/12
ACT Carotid Stent System Abbott Vascular
Temecula, CA
92591
Reduce the number of samples used from each lot during pyrogen testing.
P040040/S021
6/6/12
AMPLATZER Muscular VSD Occluders AGA Medical Corporation
Plymouth, MN
55442
Use of different braiding equipment to reduce the potential for abrasion of Nitinol wire.
P050006/S028
6/1/12
Gore Helex Septal Occluder W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Modification to a specification of a raw component for the manufacturing of the subject device.
P050012/S047
6/29/12
Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121
Manufacturing change to semi-automate the assembly and ultraviolet bonding
process for the cannula carrier (MT9754-01), pushrod carrier (MT9755-01) and needle carrier
(MT9576-02) assemblies used in the sensor applicator component of the device.
P050047/S025
6/7/12
JUVÉDERM Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Scale-up of an in-process manufacturing step of the device.
P060002/S026
6/18/12
Bard FLAIR Endovascular Stent Graft C. R. Bard, Inc.
Tempe, AZ
85281
Addition of a quality control measuring microscope for component inspection.
P060027/S040
6/11/12
Paradym CRT-D, RF CRT-D Sorin CRM USA, Inc.
Plymouth, MN
55441
Alternate manufacturing equipment.
P060029/S004
6/29/12
Ethicon Omnex Surgical Sealant Ethicon, Inc.
Somerville, NJ
08876
Transfer of the incoming inspection process from Ethicon, Inc. in Raleigh, North Carolina to Ethicon LLC in San Lorenzo, Puerto Rico.
P070026/S006
6/15/12
Ceramax Ceramic Total Hip System DePuy Orthopaedics Inc.
Warsaw, IN
46581
Changes to the device sterile packaging.
P080007/S014
6/18/12
Bard E-LUMINEXX Vascular Stent C. R. Bard, Inc.
Tempe, AZ
85281
Addition of a quality control measuring microscope for component inspection.
P080011/S012
6/19/12
CooperVision Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Relocation and revalidation of a manufacturing line number 3.
P080025/S031
6/5/12
InterStim Therapy for Bowel Control Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of an alternate qualified sub-tier supplier for components used in patient programmers.
P080025/S032
6/8/12
InterStim® Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of a new sealer used to heat seal adhesive coated lids to thermoformed plastic blister style trays.
P080025/S033
6/7/12
SNS Bowel Screening Systems/SNS Bowel Accessories/SNS
Bowel InterS tim Family of Implantable Neurostimulators/ SNS Bowel Leads/ SNS Bowel Extensions/SNS Bowel Accessories
Medtronic, Inc.
Minneapolis, MN
55432
Update the software used at several Medtronic’s manufacturing facilities.
P090002/S004
6/15/12
Pinnacle CoMplete Ceramic-on-Metal Acetabular Hip System DePuy Orthopaedics Inc.
Warsaw, IN
46581
Changes to the device sterile packaging.
P100021/S017
6/7/12
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Inclusion of manufacturing for an additional stent ring size for the device at Empalme, Mexico.
P110001/S004
6/7/12
Herculink Elite Renal Stent System Abbott Vascular
Temecula, CA
92591
Changes to the extruded tubing process.
P110001/S005
6/21/12
RX Herculink Elite Renal and Biliary Stent System Abbott Vascular
Temecula, CA
92591
Reduce the number of samples used from each lot during pyrogen testing.
P110019/S019
6/7/12
XIENCE PRIME and XIENCE PRIME Everolimus Eluting Coronary Stent Systems (EECSS) Abbott Vascular
Temecula, CA
92591
Changes to the extruded tubing process.
P110019/S021
6/18/12
XIENCE PRIME Coronary Stent System Abbott Vascular
Temecula, CA
92591
Removal of a final product test for reliability engineering.
P110023/S001
6/6/12
EverFlex Self-Expanding Peripheral Stent System Ev3, Inc.
Plymouth, MN
55441
Addition of a 7-pallet sterilizer vessel at the contract sterilizer.
P110023/S002
6/14/12
EverFlex Self- Expanding Peripheral Stent System Ev3, Inc.
Plymouth, MN
55441
Reduction of the UV intensity used to cure the bonding adhesive of the manifold sub- assembly process.
P110028/S001
6/7/12
Absolute Pro Vascular Self-Expanding Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Changes to the extruded tubing process.
P110028/S002
6/20/12
Absolute Pro Vascular Self-Expanding Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Reduction of sampling frequency for a manufacturing process.
P110028/S003
6/21/12
Absolute Pro Vascular Self-Expanding Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Reduce the number of samples used from each lot during pyrogen testing.
P110035/S001
6/6/12
Epic Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Update to a supplier gel rating methodology and specification.

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 64

Summary of PMA Originals Under Review
Total Under Review: 65
Total Active: 30
Total On Hold: 35
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 573
Total Active: 407
Total On Hold: 166
Number Greater Than 180 Days: 4

Summary of All PMA Submissions Received
Originals: 2
Supplements: 76

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 64
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 221.8
FDA Time: 188.6Days MFR Time: 33.2 Days