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U.S. Department of Health and Human Services

Medical Devices

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September 2013 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P110040
9/19/13
Medtronic Vascular Complete® SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for the Medtronic Vascular Complete® SE Vascular Stent System. This device is indicated to improve luminal diameter in symptomatic patients with de novo and/or restenotic lesions or occlusions of the superficial femoral artery (SFA) or proximal popliteal artery (PPA) with reference diameters ranging from 4 mm to 7 mm and lesion lengths up to 140 mm.
P120010
9/26/13
MiniMed 5300 SystemMedtronic, Inc.
Northridge, CA 91325
Approval for the MiniMed 5300 System. This device is indicated for the following: MiniMed 530G System - The MiniMed 530G System is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value.  The MiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, EnliteTM Sensor, EnliteTM Serter, the MiniLink Real-Time System, the Bayer Contour NextLink glucose meter, Carelink® Pro Therapy Management Software for Diabetes, and CareLink® Personal Therapy Management Software for Diabetes. The system requires a prescription. The MiniMed 530G System is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G System. The MiniMed 530G System is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia himself. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user's Health Care Provider. Enlite® Sensor- The Enlite Sensor is intended for use with Medtronic MiniMed 530G Insulin pump (models MMT-551, MMT-751) to continuously monitor glucose levels in persons with diabetes. Enlite® Serter - The Enlite Serter is used as an aid for inserting the Enlite sensor. It is indicated as a single patient use device and it is not intended for multiple-patient use. CareLinK..W Pro- CareLink Pro is designed to enhance Health Care Provider  management of diabetic patients using Medtronic insulin pumps and glucose monitors and is intended for use as a tool to help manage diabetes. The purpose of this system is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink Pro reports. The reports provide information that can be used to identify trends and track daily activities-such as carbohydrates consumed, meal times, insulin delivery and glucose readings. CareLink@ Personal - CareLink Personal is intended for use within the home and Health Care Provider environments. CareLink Personal is intended for use as a tool to help control diabetes. The purpose of this system is to take information transmitted from insulin pumps, continuous glucose monitors and glucose meters, and logbook data entered by the patient, and turn it into CareLink Personal reports. MiniLink Real-Time System - The MiniLink Real Time System consists of the MiniLink Transmitter, a tester and a charger. When connected to a sensor that is inserted in the body, the transmitter automatically initializes the sensor and begins to periodically send glucose data to the pump using a radio signal.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P790002/S030
9/12/13
Special
Biomet EBI Bone Healing SystemBiomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Approval for implementing a complimentary quality control procedure.
P790007/S038
9/24/13
135-Day
Hancock Modified Orifice Valved ConduitMedtronic Heart Valves
Santa Ana, CA 92705
Installation of a new reverse osmosis, de-ionized water system.
P850022/S020
9/12/13
Special
The Biomet OrthoPak Non-invasive Bone Growth Stimulator System, The Biomet SpinalPak Non-invasive Spine Fusion Stimulator SystemBiomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Approval for implementing a complimentary quality control procedure.
P870078/S021
9/24/13
135-Day
Hancock Porcine BioprosthesisMedtronic Heart Valves
Santa Ana, CA 92705
Installation of a new reverse osmosis, de-ionized water system.
P890003/S260
9/5/13
180-Day
Carelink Programmer C, ProgrammerMedtronic, Inc.
Mounds View, MN 55112
Approval for multiple design changes, packaging changes, labeling changes, manufacturing process changes, and a manufacturing facility transfer to Technical Services for Electronics, Inc., TSE Taiwan manufacturing facility, with packaging activities to occur at the TSE facility in Jackson, Minnesota for the 2090 EC/ECL ECG Cable and Lead Wires and 148743 ECG Plug.
P890003/S280
9/27/13
180-Day
MyCareLink Patient MonitorMedtronic, Inc.
Mounds View, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950 (software version R50), 24951 (software version R50.A.1), and 24955 (software version V29) to be used with the devices.
P890055/S049
9/20/13
Special
MedStream Programmable Infusion SystemCodman & Shurtleff, Inc.
Raynham, MA 02767
Approval for labeling modifications to provide users with information regarding steps that should be taken to prevent a potential adverse reaction when filling the pump reservoir.
P900056/S123
9/24/13
135-Day
Rotablator Rotational Atherectomy SystemBoston Scientific, Corporation
Maple Grove, MN 55311
Vendor change for the Rotaglide Lubricant.
P920015/S108
9/10/13
135-Day
SPRINT QUATTRO LEAD, SPLITTER/
ADAPTOR
Medtronic, Inc.
Mounds View, MN 55112
Approval for the implementation of a new inspection fixture at the supplier.
P950009/S015
9/13/13
180-Day
BD FocaiPoint Slide ProfilerBD Diagnostics
Durham, NC
27703
Approval for the BD FocalPoint Slide Profiler with the new digital primary camera.
P950027/S014
9/26/13
Real-Time
Hyalgan®Fidia Farmaceutici, S.p.A.
Via Ponte Della Fabbrica, Italy
Approval for a new injection syringe (denoted as “EZ-fill Syringe”) for Hyalgan® that incorporates a tamper-evident closure system consisting of a seal, a tip cap, and a Luer lock.
P950037/S127
9/26/13
Real-Time
Ecuro, Effecta, Entovis, Estella, Evia Family of Pulse GeneratorsBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an alternate separator material used in the Greatbatch batteries for the devices.
P950037/S128
9/26/13
Real-Time
Philos DR-T, Philos II DR-T, Cylos DR-T, Evia DR-T, Evia SR-T, Entovis DR-T, Entovis
SR-T, Estella DR-T, Estella SR-T, Ecuro DR-T, Ecuro SR-T, Effecta DR-T, Effecta SR-T
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the application software version PSW 1301.U of the Programmer Models Renamic and ICS 3000 for the devices.
P960004/S060
9/9/13
180-Day
FINELINE II Sterox Lead FamilyBoston Scientific Corporation
St. Paul, MN
55112
Approval to change the primer formulation used on FINELINE II lead subassemblies, as well as to relocate manufacturing of some subassemblies in-house with minor associated design changes.
P960009/S156
9/13/13
180-Day
Medtronic Activa Parkinson’s Control TherapyMedtronic Neuromodulation
Minneapolis, MN 55432
Approval for an update to the labeling to incorporate PAS study data.
P960058/S101
9/17/13
135-Day
HiResolution Bionic Ear SystemAdvanced Bionics
Sylmar, CA
91342
Improvement to the HiResolution Bionic Ear System’s hybrid inspection process.
P970003/S164
9/23/13
Real-Time
VNS Therapy SystemCyberonics, Inc
Houston, TX
77058
Approval for a design change to the in-line test resistor that is used in conjunction with single pin pulse generators during perioperative troubleshooting.
P970031/S042
9/24/13
135-Day
Freestyle Aortic Root BioprosthesisMedtronic Heart Valves
Santa Ana, CA 92705
Installation of a new reverse osmosis, de-ionized water system.
P970053/S011
9/30/13
Panel-Track
Nidek EC-5000 Excimcr Laser SystemNidek Co., LTD
Wadsworth, OH 44281
Approval  for the Nidek EC-5000 Excimer Laser System. This device is indicated for topography-assisted Laser- Assisted In-Situ Keratomileusis (LASIK) treatment using the Final Fit™ custom ablation treatment planning software for the reduction or elimination of myopic refractive errors from -1.0 to -4.0 D of sphere with astigmatic refractive errors from >-0.5 to -2.0 D at the spectacle plane; in patients 21 years of age or older; and, in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in MRSE not greater than ±0.5 D.
P980016/S394
9/25/13
180-Day
Protecta XT, Protecta, Secura, Virtuoso II and Maximo II ICD'sMedtronic, Inc.
Mounds View, MN 55112
Approval for adding non-Medtronic defibrillation leads to Right Ventricular Lead Integrity Alert (RV LIA) labeling.
P980016/S425
9/27/13
180-Day
EnTrust ICD; Intrinsic 30 ICD;
Intrinsic ICD; Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo VR ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Marquis II ICD;
Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950 (software version R50), 24951 (software version R50.A.1), and 24955 (software version V29) to be used with the devices.
P980022/S136
9/13/13
Special
Paradigm® REAL-Time System,
Paradigm® REAL-Time Revel System
Medtronic MiniMed
Northridge, CA 91325
Approval of labeling changes to provide additional safety information regarding potential for water damage to the User Guide for the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, and MMT-722K), and for the Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723, and MMT-723K). The Paradigm REAL-Time Insulin Pumps are components of the Paradigm REAL-Time System and the Paradigm REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time Revel Systems.
P980035/S338
9/27/13
180-Day
Adapta, Versa, Sensia IPG; Advisa DR IPG; EnPulse;
EnPulse E2 IPG; EnRhythm IPG;
Kappa D (Kappa 700) IPG; Kappa D (Kappa 900) IPG; Kappa DR (Kappa 650) IPG; Kappa DR (Kappa 700/600) IPG; Kappa DR (Kappa 900/800) IPG; Kappa SR (Kappa 700) IPG; Kappa SR (Kappa 900) IPG;
Kappa VDD (Kappa 700) IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950 (software version R50), 24951 (software version R50.A.1), and 24955 (software version V29) to be used with the devices.
P980043/S042
9/24/13
135-Day
Hancock® II Porcine BioprosthesisMedtronic Heart Valves
Santa Ana, CA 92705
Installation of a new reverse osmosis, de-ionized water system.
P990009/S035
9/19/13
180-Day
Floseal Hemostatic MatrixBaxter Healthcare Corporation
Round Lake, IL 60073
Approval to change the warning statement ‘the safety and effectiveness has not been established in children under 2 years of age and pregnant women’.
P990064/S050
9/24/13
135-Day
Mosaic® Porcine BioprosthesisMedtronic Heart Valves
Santa Ana, CA 92705
Installation of a new reverse osmosis, de-ionized water system.
P990074/S023
9/10/13
180-Day
Natrelle® Saline-Filled Breast ImplantAllergan
Goleta, CA
93117
Approval for physician and patient labeling revisions to include information about Anaplastic Large Cell Lymphoma (ALCL) and Connective Tissue Disease (CTD) risks with the Natrelle® Saline-Filled Breast Implant.
P000009/S055
9/26/13
Real-Time
Lumos VR-T 353 219, Lumos DR-T 353 220Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the application software version PSW 1301.U of the programmer Models Renamic and ICS 3000 for the devices.
P000025/S070
9/25/13
Real-Time
MED-EL COMBI 40+ Cochlear Implant System,
MED-EL Reusable Surgical Tools
MED-EL Corporation
Durham, NC
27713
Approval for updating the reprocessing instructions for all currently approved MED-EL reusable surgical tools.
P010015/S208
9/27/13
180-Day
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950 (software version R50), 24951 (software version R50.A.1), and 24955 (software version V29) to be used with the devices.
P010015/S209
9/16/13
Real-Time
Attain Bipolar OTW LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a minor modification to the anchoring sleeve installed on the Attain Bipolar OTW Lead Model 4194.
P010023/S010
9/13/13
Real-Time
MAXUMOtotronix LLC
St. Paul, MN
55127
Approval for user interface software changes and patient fitting changes to the OptiMax Programmer Software.
P010031/S344
9/25/13
180-Day
Protecta XT, Protecta, Consulta, Concerto II, Maximo II CRT-D'sMedtronic, Inc.
Mounds View, MN 55112
Approval for adding non-Medtronic defibrillation leads to Right Ventricular Lead Integrity Alert (RV LIA) labeling.
P010031/S386
9/27/13
180-Day
InSync III Marquis, InSync Marquis, InSync Maximo, Insync II Protect; Brava CRT-D;
Concerto ICD; Concerto II CRT-D; Consulta ICD;
Maximo II CRT-D;
Protecta CRT-D; Protecta XT CRT-D; Viva S CRT-D; Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950 (software version R50), 24951 (software version R50.A.1), and 24955 (software version V29) to be used with the devices.
P010047/S030
9/25/13
Real-Time
Progel™ Pleural Air Leak SealantNeomend, Inc.
Irvine, CA
92618
Approval for removal of the upper limit seal strength specification for the sterile barrier pouch packaging and replacing it with the peel-open verification test.
P020009/S107
9/5/13
135-Day
Express2 Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Approval for use of a semi-automated Point-N-Click System for the distal weld inspection.
P020045/S050
9/27/13
180-Day
CryoCath Freezor® CryoAblation CatheTer System (CryoFACTS)Medtronic Cryocath
Mounds View, MN 55112
Approval of the post-approval study protocol.
P020050/S012
9/27/13
Panel-Track
ALLEGRETTO WAVE® Eye-Q 400Hz Excimer Laser SystemAlcon Research, Ltd.
Cincinnati, OH 45220
Approval for the ALLEGRETTO WAVE® Eye-Q 400Hz Excimer Laser System. This device is indicated for the following: The WaveLight ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight ALLEGRO Topolyzer (topographer) and T-CAT treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (Topo-guided (T-CAT) LASIK): 1) for the reduction or elimination of up to -9.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 D of spherical component and up to -3.00D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as 0.50D or less of preoperative spherical equivalent shift over one year prior to surgery.”
P040016/S113
9/5/13
135-Day
VeriFlex (Liberte) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Approval for use of a semi-automated Point-N-Click System for the distal weld inspection.
P040043/S051
9/10/13
Panel-Track
GORE TAG Thoracic EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for the GORE TAG Thoracic Endoprosthesis. This device is intended for endovascular repair of all lesions of the descending thoracic aorta, including: 1)  Isolated lesions in patients who have appropriate anatomy, including: a) Adequate iliac/femoral access; b) Aortic inner diameter in the range of 16-42 mm; and c) > 20 mm non-aneurysmal aorta proximal and distal to the lesion. 2) Type B dissections in patients who have appropriate anatomy, including: a) Adequate iliac/femoral access; b) > 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected; and c) Diameter at proximal extent of proximal landing zone in the range of 16-42 mm.
P050023/S069
9/26/13
Real-Time
Lumax 300 DR-T, Lumax 340 DR-T, Lumax 300 VR-T, Lumax 340 VR-T, Lumax 500
DR-T, Lumax 540 DR-T, Lumax 500 VR-T, Lumax 540 VR-T, Lumax 540 VR-T DX,
Lumax 600 DR-T, Lumax 640 DR-T, Lumax 600 VR-T, Lumax 640 VR-T, Lumax 640
VR-T DX, Lumax 700 DR-T, Lumax 740 DR-T, Lumax 700 VR-T, Lumax 740 VR-T,
Lumax 740 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T, Ilesto 7 VR-T DX,Ilesto 5 VR-T DX,
Ilesto 7 DR-T, Ilesto 5 DR-T, Iforia 7 VR-T, Iforia 5 VR-T, Iforia 7 VR-T DX, Iforia 5
VR-T DX, Iforia 7 DR-T, Iforia 5 DR-T, Lumax 300 HF-T, Lumax 340 HF-T, Lumax 500
HF-T, Lumax 540 HF-T, Lumax 600 HF-T, Lumax 640 HF-T, Lumax 700 HF-T, Lumax
740 HF-T, Ilesto 7 HF-T, Ilesto 5 HF-T, Iforia 7 HF-T, Iforia 5 HF-T
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the application software version PSW 1301.U of the programmer Models Renamic and ICS 3000 for the devices.
P050026/S001
9/26/13
180-Day
Qcellus LaserQLT Incorporated
Vancouver, BC
Canada
V5T 4T5
Approval for: 1) change in the name of the device from Activis Laser to Qcellus Laser; 2) change in the laser design to combine the laser module and slit lamp adapter into a single unit to be mounted directly on the tonometer post of a Haag-Streit 900 BM/BQ slit lamp or equivalent; and 3) change manufacturing site for the Qcellus Laser to QLT, Inc., Vancouver, BC, Canada.
P050027/S005
9/23/13
180-Day
Karl Storz Photodynamic
D-light System
Karl Storz
Tuttlingen, Germany
78532
Approval for a manufacturing site located at Karl Storz GmbH & Co., in  Tuttlingen, Germany to manufacture the C light source.
P060040/S028
9/25/13
Real-Time
Thoratec HeartMate II Left Ventricular Assist System (LVAS)Thoratec Corporation
Pleasanton, CA 94588
Approval for a design change to the Universal Battery Charger.
P070006/S011
9/3/13
135-Day
T-SPOT®.TB TestNew World Regulatory Solutions, Inc.
Toms River, NJ 08754
Approval for a change to reduce the volume of coating antibody for the Microcoat GmBH (Microcoat) plates included in the T-SPOT®.TB test kits.
P070008/S046
9/26/13
Real-Time
Entovis HF(-T), Evia HF(-T) Family of CRT-P DevicesBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an alternate separator material used in the Greatbatch batteries for the devices.
P070008/S047
9/26/13
Real-Time
Stratos LV-T, Evia HF-T, Entovis HF-TBiotronik, Inc.
Lake Oswego, OR 97035
Approval for the application software version PSW 1301.U of the programmer Models Renamic and ICS 3000 for the devices.
P070015/S111
9/23/13
135-Day
XIENCE V® Everolimus Eluting Coronary Stent System and XIENCE nano® Everolimus Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA 92591
Approval for the discontinuation of the molecular weight and polydispersity tests from the annual stability testing.
P080026/S008
9/10/13
Real-Time
Abbott RealTime HBV AssayAbbott Molecular, Inc.
Des Plaines, IL 60018
Approval for a change to a data reduction parameter in the application specification files.
P090013/S107
9/27/13
180-Day
Revo MRIMedtronic, Inc.
Mounds View, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950 (software version R50), 24951 (software version R50.A.1), and 24955 (software version V29) to be used with the devices.
P100003/S002
9/6/13
Real-Time
SECURE®-C Cervical Artificial DiscGlobus Medical, Incorporated
Audubon, PA
19403
Approval for additional device-specific instrumentation associated with the SECURE®-C Cervical Artificial Disc.
P100017/S005
9/25/13
180-Day
Abbott RealTime HCVAbbott Molecular, Inc.
Des Plaines, IL 60018
Approval for the addition of an optional extended use feature to allow prepared amplification master mix and internal control to be used a second time within 14 days of initial use if stored at -25°C to -15°C; 2) Process improvements to the liquid level sensing performed by the Abbott m2000sp instrument; 3) The conversion of manual plate filling to automated plate filling; and 4) Associated software revisions.
P100039/S002
9/26/13
Real-Time
ADVIA Centaur® Anti-HBs2 (aHBs2) Assay, ADVIA Centaur® Anti-HBs2 (aHBs2)
Quality Control Material, and ADVIA Centaur® Anti-HBs2 Master Curve Material
Siemens Healthcare Diagnostics, Inc.
Tarytown, NY 10591
Approval for the AD VIA Centaur Anti-HBs2 (aHBs2) Master Curve Material. The device, as modified, will be marketed under the trade name AD VIA Centaur AntiHBs2 (aHBs2) Assay, ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, and ADVIA Centaur Anti-HBs2 (aHBs2) Master Curve Material and is indicated for: ADVIA Centaur Anti-HBs2 (aHBs2) Assay:  The ADVIA Centaur Anti-HBs2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative detennination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum or plasma (EDTA, lithium-heparinized, or sodium-heparinized) and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP systems. The assay results may be used as an aid in the detennination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been FDA-cleared or approved for the screening of blood or plasma donors. ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material:  For in vitro diagnostic use in monitoring the performance of the Anti-HBs2 assay on the ADVIA Centaur Systems. The performance of the Anti-HBs2 quality control material has not been established with any other Anti-HBs assays. ADVIA Centaur Anti-HBs2 (aHBs2) Master Curve Material:  The ADVIA Centaur Anti-HBs2 (aHBs2) Master Curve Material (MCM) is for in vitro use in the verification of calibration and reportable range of the AD VIA Centaur aHBs2 assay.
P100041/S039
9/23/13
180-Day
Edwards SAPIEN™ Transcatheter Heart Valve and accessories RetroFlex 3™ Delivery System; RetroFlex™ Balloon Catheter; Edwards Balloon Catheter; RetroFlex 3™ Introducer Sheath Set; RetroFlex™ Dilator Kit; and CrimperEdwards Lifesciences LLC
Irvine, CA
92614
Approval for removal of access approach from device labeling. The device is indicated for patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be: 1) inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or 2) be operative candidates for aortic valve replacement but who have a predicted operative risk score ≥ 8% or are judged by the heart team to be at a ≥ 15% risk of mortality for surgical aortic valve replacement.
P110010/S054
9/27/13
135-Day
PROMUS Element™ Plus Everolimus-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Approval for updates to the software and hardware of the balloon molding towers.
P110013/S016
9/12/13
180-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for a revised elution specification.
P110013/S020
9/5/13
135-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA 95403
Approval for changing the sampling scheme used for analytical lot release testing for the devices.
P110021/S023
9/13/13
180-Day
Edwards SAPIEN Transcatheter Heart Valve with RetroFlex 3 Delivery System, RetroFlex Balloon Catheter, Ascendra Delivery System, Ascendra Balloon Catheter and CrimperEdwards LifeSciences, LLC.
Irvine, CA
92614
Approval of the post-approval study protocol.
P110021/S026
9/23/13
180-Day
Edwards SAPIEN™ Transcatheter Heart Valve; and accessories RetroFlex 3™ Delivery System; Ascendra 3™ Delivery System; RetroFlex™ Balloon Catheter; Edwards Balloon Catheter; Ascendra™ Balloon Aortic Valvuloplasty Catheter; RetroFlex 3™ Introducer Sheath Set; Ascendra™ Introducer Sheath Set; RetroFlex™ Dilator Kit; and CrimperEdwards Lifesciences LLC
Irvine, CA
92614
Approval for removal of access approach from device labeling. The device is indicated for patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be: 1) inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or 2) be operative candidates for aortic valve replacement but who have a predicted operative risk score ≥ 8% or are judged by the heart team to be at a ≥ 15% risk of mortality for surgical aortic valve replacement.
P110042/S014
9/27/13
Real-Time
Subcutaneous Implantable Defibrillator S-ICD SystemCameron Health, Inc.
San Clemente, CA 92673
Approval for two alternate silicon capacitors used on the Low Power Hybrid Assembly for the S-ICD System.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N12159/S032
9/12/13
Surgicel Absorbable HemostatEthicon, Inc.
Somerville, NJ 08876
Implement a new automatic cartoner for the Surgicel Absorbable Hemostat packaged material.
N17679/S036
9/13/13
Methafilcon A, Methafilcon B, and Tetrafilcon A Extended Wear Contact LensesCooperVision, Incorporated
Pleasanton, CA
94588
Change to the sterilization cycle.
N970003/S155
9/25/13
PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO,
and INGENIO Pacemakers
Boston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P830026/S082
9/25/13
COSMOS PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P830060/S076
9/25/13
VENTAK Implantable Cardioverter DefibrillatorsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P840068/S053
9/25/13
DELTA / VISTA PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P850064/S025
9/24/13
Life Pulse High Frequency VentilatorBunnell Incorporated
Salt Lake City, UT 84115
Change to the LifePort Test Fixture.
P850079/S065
9/13/13
Methafilcon A, Methafilcon B, and Tetrafilcon A Extended Wear Contact LensesCooperVision, Incorporated
Pleasanton, CA
94588
Change to the sterilization cycle.
P860057/S111
9/20/13
Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue processEdwards Lifesciences, LLC
Irvine, CA
92614
Update to the tissue fixation system using a new automated process.
P860057/S112
9/23/13
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process;
Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process; Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis;
Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process;
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process; Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis;
Carpentier-Edwards PERIMOUNT Theon Pericardial Mitral Bioprosthesis with ThermaFix Tissue Process;
Carpentier-Edwards PERIMOUNT Magna Mitral Pericardial Bioprosthesis; Carpentier-Edwards PERIMOUNT Magna Mitral Pericardial Bioprosthesis with ThermaFix Tissue Process; Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis; Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix Tissue Process; Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix Tissue Process; Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis; Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix Tissue Process
Edwards Lifesciences LLC
Irvine, CA
92614
Changing the silicone gasket material (supplied by St. Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for all Edwards heart valves.
P870056/S061
9/23/13
Carpentier-Edwards Porcine Aortic Bioprosthesis;  Carpentier-Edwards Porcine Mitral BioprosthesisEdwards Lifesciences LLC
Irvine, CA
92614
Changing the silicone gasket material (supplied by St. Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for all Edwards heart valves.
P870077/S055
9/23/13
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring; Carpentier-Edwards Duraflex Low Pressure Porcine Mitral BioprosthesisEdwards Lifesciences LLC
Irvine, CA
92614
Changing the silicone gasket material (supplied by St. Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for all Edwards heart valves.
P880086/S234
9/5/13
Accent DR/SR RF PacemakersSt. Jude Medical
Sylmar, CA
91342
Change in the encapsulation cure process for the left ventricular radiofrequency (LV RF) Modules in the devices.
P890055/S050
9/23/13
MedStream Programmable Infusion SystemCodman and Shurtleff, Inc.
Raynham, MA 02767
Removal of a duplicate visual inspection performed on two accessory components packaged with the MedStream Intrathecal Catheter.
P890055/S051
9/27/13
MedStream Programmable Infusion SystemCodman and Shurtleff, Inc.
Raynham, MA 02767
Manufacturing change to the bonding operation of the MedStream Pump sub-assembly.
P890061/S023
9/25/13
VENTAK P Implantable Cardioverter DefibrillatorsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P900056/S125
9/6/13
Rotablator Rotational Atherectomy SystemBoston Scientific Corporation
Maple Grove, MN 55311
Replacing the short drive laser welder used in the RotaLink Advancer and Catheter manufacturing lines.
P900056/S126
9/27/13
Rotablator® Rotational Atherectomy SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P910073/S120
9/17/13
ENDOTAK RELIANCE® 4-SITE Defibrillation LeadsBoston Scientific Corporation
St. Paul, MN
55112
Add a new primary supplier of the serial number labels for the defibrillation leads and coronary sinus leads for the devices.
P910073/S121
9/25/13
ENDOTAK Implantable Cardioverter Defibrillator LeadsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P910077/S137
9/25/13
VENTAK PRx and VENTAK MINI Implantable Cardioverter
Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P920047/S059
9/27/13
Blazer® II, Blazer® II HTD, and Blazer Prime®HTD Temperature Ablation CathetersBoston Scientific Corporation
Maple Grove, MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P930031/S047
9/27/13
WALLSTENT® TIPS EndoprosthesisBoston Scientific Corporation
Maple Grove, MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P930035/S025
9/25/13
VENTAK P2 Implantable Cardioverter DefibrillatorsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P940019/S040
9/27/13
WALLSTENT® Iliac EndoprosthesisBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P940031/S075
9/25/13
VIGOR DR/SR, DISCOVERY, MERIDIAN PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P950001/S026
9/25/13
SELUTE Pacing LeadsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P950005/S045
9/5/13
Celsius Catheter, Celsius RMT Catheter, EZ Steer catheter, EZ Steer DS Catheter, Celsius FLTR CatheterBiosense Webster, Inc.
Diamond Bar, CA 91765
Increasing the range of the final chamber temperature during Dynamic Conditioning, lowering the minimum load temperature during the ethylene oxide (EO) Dwell phase, and changing of the measurement period when measuring EO concentration during the EO Dwell phase.
P950020/S064
9/27/13
Flextome® Cutting Balloon® Dilatation DeviceBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P950029/S083
9/26/13
Reply SR, Reply DR, Esprit SR, Esprit DRSorin CRM USA, Inc.
Arvada, CO
80004
Change in the test methodology employed during bench testing of the components and finished device.
P960004/S063
9/25/13
THINLINE/ FINELINE Pacing LeadsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P960006/S040
9/25/13
SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND Pacing
Leads
Boston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P960040/S303
9/19/13
PUNCTUA, TELIGEN,
ENERGEN and
INCEPTA Implantable Cardioverter Defibrillator
Boston Scientific Corporation
St. Paul, MN
55112
Change to the Capacitor Epoxy Process for the devices.
P960040/S304
9/25/13
VENTAK AV and VENTAK PRIZM DR/VR, VITALITY,
CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, and INCEPTA ICD Implantable Cardioverter Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P960040/S305
9/26/13
TELIGEN®, INCEPTA® ICD, ENERGEN® ICD and PUNCTUA® ICDBoston Scientific Corporation
St. Paul, MN
55112
Implementation of a vacuum based system at a supplier to eliminate contaminates in the cavities of the pulse generator headers.
P960043/S084
9/25/13
Perclose ProGlide® Suture Mediated Closure System;
Perclose AT® 6F Suture Mediated Closure System
Abbott Vascular Inc.
Santa Clara, CA 95054
Removing a redundant inspection for bleedback lumen patency from the manufacturing process.
P960058/S104
9/18/13
HiResolution Bionic Ear SystemAdvanced Bionics
Sylmar, CA
91342
Addition of an alternate capacitor supplier.
P970003/S165
9/5/13
VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Changes to the Automated Functional Test software.
P980003/S039
9/4/13
Chilli II Cooled Ablation CatheterBoston Scientific Corporation
San Jose, CA
95134
Change to an in-process inspection frequency for the electrode ring adhesive component of the Chilli II Cooled Ablation Catheter.
    
P890003/S040
9/27/13
Chilli II Cooled Ablation CatheterBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P980016/S432
9/3/13
Evera S DR ICD;
Evera S VR ICD;
Evera XT DR ICD;
Evera XT VR ICD
Medtronic CRDM
Mounds View, MN 55112
L404 IC test changes for the devices.
P980022/S137
9/24/13
Paradigm REAL-Time System
Paradigm REAL-Time Revel System
Medtronic MiniMed
Northridge, CA 91325
Addition of an alternate facility warehouse space for the handling of raw materials including subassemblies and components for the Paradigm REAL-Time Insulin Pumps (MMT-522, MMT-522K, MMT-722, MMT-722K) and Paradigm REAL-Time Revel Insulin Pumps (MMT-523, MMT-523K, MMT-723, MMT-723K). The Paradigm REAL-Time Insulin Pumps are components of the Paradigm REAL-Time System and the Paradigm REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time Revel System.
P980033/S036
9/27/13
WALLSTENT® Venous EndoprosthesisBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P980035/S342
9/12/13
ADVISA DR, ADVISA DR MRIMedtronic, Inc.
Mounds View, MN 55112
Addition of a laser welder at the battery supplier.
P980035/S344
9/26/13
ADAPTA, VERSA, SENSIA, RELIAMedtronic, Inc.
Mounds View, MN 55112
Expand the hybrid lot identification (ID) character format.
P980049/S086
9/26/13
Paradym VR 8750, Paradym DR 8750, Paradym RF VR 9750,  Paradym RF DR 9750Sorin CRM USA, Inc.
Arvada, CO
80004
Change in the test methodology employed during bench testing of the components and finished device.
P990025/S038
9/5/13
NaviStar RMT Catheter, EZ Steer NAV Catheter, Biosense Webster CablesBiosense Webster, Inc.
Diamond Bar, CA 91765
Increasing the range of the final chamber temperature during Dynamic Conditioning, lowering the minimum load temperature during the ethylene oxide (EO) Dwell phase, and changing of the measurement period when measuring EO concentration during the EO Dwell phase.
P990071/S024
9/5/13
Biosense Webster CablesBiosense Webster, Inc.
Diamond Bar, CA 91765
Increasing the range of the final chamber temperature during Dynamic Conditioning, lowering the minimum load temperature during the ethylene oxide (EO) Dwell phase, and changing of the measurement period when measuring EO concentration during the EO Dwell phase.
P000007/S042
9/23/13
Edwards Prima Plus Stentless Porcine BioprosthesisEdwards Lifesciences LLC
Irvine, CA
92614
Changing the silicone gasket material (supplied by St. Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for all Edwards heart valves.
P000012/S044
9/12/13
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites
P000043/S022
9/18/13
TherMatrx Office Thermotherapy SystemAmerican Medical Systems, Inc.
Minnetonka, MN 55343
Change in sterilization monitoring process, change in the order of labeling, and change in pouch orientation.
P010003/S017
9/6/13
BioGlue Surgical AdhesiveCryoLife, Inc.
Kennesaw, GA 30144
Addition of a service supplier for pouching the Delivery Tip Extension.
P010012/S338
9/17/13
ACUITY™ Spiral IS-1 Coronary sinus leads, EASYTRAK® 2 IS-1 Coronary Sinus Leads, EASYTRAK® 3 IS-1 Coronary Sinus LeadsBoston Scientific Corporation
St. Paul, MN
55112
Add a new primary supplier of the serial number labels for the defibrillation leads and coronary sinus leads for the devices.
P010012/S339
9/19/13
PUNCTUA, COGNIS, ENERGEN and INCEPTA Cardiac Resynchronization Therapy-DefibrillatorBoston Scientific Corporation
St. Paul, MN
55112
Change to the Capacitor Epoxy Process for the devices.
P010012/S340
9/25/13
CONTAK CD, EASYTRAK, LIVIAN, COGNIS, PUNCTUA
CRT-D, ENERGEN CRT-D, and INCEPTA CRT-D Cardiac
Resynchronization Therapy Defibrillators
Boston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P010015/S213
9/19/13
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Changes to the epoxy dispense and weld bracket inspection for the devices.
P010015/S214
9/12/13
CONSULTA, SYNCRAMedtronic, Inc.
Mounds View, MN 55112
Addition of a laser welder at the battery supplier.
P010031/S393
9/3/13
Brava CRT-D;
Viva S CRT-D;
Viva XT CRT-D
Medtronic CRDM
Mounds View, MN 55112
L404 IC test changes for the devices.
P010041/S044
9/23/13
Carpentier-Edwards S.A.V. Aortic Porcine BioprosthesisEdwards Lifesciences LLC
Irvine, CA
92614
Changing the silicone gasket material (supplied by St. Gobain) for the 3.8 oz. jar cap gasket used in the finished-device packaging container for all Edwards heart valves.
P010068/S035
9/5/13
Celsius DS Catheter, Navistar DS Catheter, Navistar RMT DS Catheter, EZ Steer Nav DS Catheter, Celsius FLTR CatheterBiosense Webster, Inc.
Diamond Bar, CA 91765
Increasing the range of the final chamber temperature during Dynamic Conditioning, lowering the minimum load temperature during the ethylene oxide (EO) Dwell phase, and changing of the measurement period when measuring EO concentration during the EO Dwell phase.
P020009/S109
9/27/13
Express2® Coronary Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P020025/S043
9/27/13
Maestro 3000™ Cardiac Ablation System and Accessories, and Blazer® II XP, Blazer Prime® XP Ablation CathetersBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P030005/S102
9/25/13
CONTAK RENEWAL TR and INVIVE Cardiac Resynchronization
Therapy Pacemakers
Boston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P030009/S067
9/18/13
Integrity Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA 95403
Change to the labeling inspection process.
P030017/S177
9/20/13
Precision Spinal Cord Stimulator SystemBoston Scientific Corporation
Valencia, CA
91355
Update the test software for checking the battery profile of the Implantable Pulse Generator.
P030017/S178
9/20/13
Precision Spectra Spinal Cord Stimulator SystemBoston Scientific Corporation
Valencia, CA
91355
Add an alternate qualified supplier for the printed circuit board.
P030017/S179
9/26/13
Precision and Precision Spectra Spinal Cord Stimulator (SCS) SystemsBoston Scientific Corporation
Valencia, CA
91355
Change the solder fillet height requirement for the Printed Circuit Board Assembly.
P030024/S021
9/6/13
VITROS Immunodiagnostics Products Anti-HBc Reagent Pack,
VITROS Immunodiagnostics Products Anti-HBc Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Removal of greyzone samples from a Quality Control release test method.
P030031/S055
9/5/13
Celsius Thermocool Catheter, Celsius RMT Thermocool Catheter, Navistar Thermocool Catheter, Navistar RMT Thermocool CatheterBiosense Webster, Inc.
Diamond Bar, CA 91765
Increasing the range of the final chamber temperature during Dynamic Conditioning, lowering the minimum load temperature during the ethylene oxide (EO) Dwell phase, and changing of the measurement period when measuring EO concentration during the EO Dwell phase.
P030035/112
9/5/13
Anthem RF CRT-P DevicesSt. Jude Medical
Sylmar, CA
91342
Change in the encapsulation cure process for the left ventricular radiofrequency (LV RF) Modules in the devices.
P040008/S007
9/12/13
VIDAS® Total PSA AssaybioMérieux, Inc.
Hazelwood, MO 63042
Review of bioMérieux's expansion to the manufacturing facility in Marcy l'Etoile (France).
P040014/S020
9/27/13
Therapy Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Additional sterilization chamber for the Therapy Series Ablation Catheters.
P040016/S115
9/27/13
Veri FLEX™ (Liberte®) Bare Metal Coronary Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P040036/S039
9/5/13
Navistar Thermocool Catheter, Navistar RMT Thermocool Catheter, EZ Steer Thermocool Catheter, EZ Steer Thermocool Nav CatheterBiosense Webster, Inc.
Diamond Bar, CA 91765
Increasing the range of the final chamber temperature during Dynamic Conditioning, lowering the minimum load temperature during the ethylene oxide (EO) Dwell phase, and changing of the measurement period when measuring EO concentration during the EO Dwell phase.
P040042/S025
9/27/13
Therapy Dual 8 Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Additional sterilization chamber for the Therapy Series Ablation Catheters.
P050019/S017
9/27/13
Carotid WALLSTENT® Monorail® Endoprosthesis pgsooos Chilli II® Cooled Ablation Catheter, Model8005 CircuCool Pump, Model2104 TubingKit, sterile cablesBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P050028/S034
9/6/13
COBAS® TaqMan HBV Test For Use With The High Pure System
cobas® AmpliPrep/cobas® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change rooms for positive control formulation and filling.
P050028/S035
9/12/13
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
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites
P050034/S011
9/3/13
Implantable Miniature Telescope (IMT)VisionCare Ophthalmic Technologies
Saratoga, CA
95070
Add an alternate supplier of a component used to manufacture the telescope.
P050037/S039
9/17/13
Radiesse Injectable Dermal FillerMerz Aesthetics, Inc.
Franksville, WI 53126
Change in flooring material and room configuration in the manufacturing environment for a raw material.
P050037/S040
9/16/13
Radiesse Injectable ImplantMerz Aesthetics, Inc.
Franksville, WI 53126
Change in the sterilization rack configuration.
P050046/S020
9/17/13
ACUITYTM Steerable IS-1 Coronary Sinus LeadsBoston Scientific Corporation
St. Paul, MN
55112
Add a new primary supplier of the serial number labels for the defibrillation leads and coronary sinus leads for the devices.
P050046/S021
9/25/13
ACUITY Pacing LeadsBoston Scientific Corporation
St. Paul, MN
55112
Use of new traceability/tracking software in the incoming receiving inspection area.
P050047/S032
9/6/13
Juvederm Hyaluronate Gel ImplantsAllergan
Goleta, CA
93117
Change the Hyaluronic Acid (HA) concentration during a manufacturing process.
P050052/S042
9/17/13
Radiesse Injectable Dermal FillerMerz Aesthetics, Inc.
Franksville, WI 53126
Change in flooring material and room configuration in the manufacturing environment for a raw material.
P050052/S043
9/16/13
Radiesse Injectable ImplantMerz Aesthetics, Inc.
Franksville, WI 53126
Change in the sterilization rack configuration.
P060002/S033
9/16/13
Bard FLAIR Endovascular Stent GraftBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Alternate tip cleaning process.
P060006/S048
9/27/13
Express® SO Renal Monorail® Premounted Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P060008/S106
9/27/13
TAXUS® Liberte® Paclitaxei-Eiuting Coronary Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P060019/S024
9/27/13
Therapy Cool Path Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Additional sterilization chamber for the Therapy Series Ablation Catheters.
P060027/S054
9/26/13
Paradym CRT-D 8750, Paradym RF CRT-D 9750Sorin CRM USA, Inc.
Arvada, CO
80004
Change in the test methodology employed during bench testing of the components and finished device.
P060030/S034
9/6/13
COBAS® AmpliPrep/ cobas® TaqMan® HCV Test COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure SystemRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change rooms for positive control formulation and filling.
P060030/S035
9/12/13
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure SystemRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites
P060033/S080
9/18/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the labeling inspection process.
P070014/S040
9/26/13
Lifestent Vascular StentBard Peripheral Vascular
Tempe, AZ
85281
Additional dimensional measuring machine for quality control Inspections.
P080004/S014
9/26/13
iSert Preloaded Posterior Chamber Intraocular LensesHoya Surgical Optics, Inc.
Chino Hills, CA 91709
Change in material for a manufacturing fixture used during the post-tumbling final washing process.
P080007/S018
9/17/13
E-Luminexx and LifeStar Vascular Stent SystemsBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Alternate lubricant formulation for the delivery system catheter tips.
P080011/S027
9/6/13
Biofinity Sphere (Comfilcon A) Soft Extended – Wear Contact LensesCooperVision
Pleasanton, CA 94588
Increase in the range of power for the Biofinity Sphere lenses.
P080023/S022
9/27/13
ARCHITECT COREAbbott Laboratories
Abbott Park, IL 60064
Addition of alternate suppliers for Anti-HBc Positive Plasma.
P080027/S013
9/26/13
OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc.
Bethlehem, PA 18015
Change to utilize a semi-automated process for assembly of the test device component and pouching of the kit components.
P090003/S027
9/27/13
Express® LD Iliac Premounted Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P090013/S111
9/12/13
REVO MRIMedtronic, Inc.
Mounds View, MN 55112
Addition of a laser welder at the battery supplier.
P090022/S019
9/19/13
Softec HD, Softec I, Softec HD PS and Softec HDO Intraocular LensesLenstec, Inc.
Saint Petersburg, FL 33716
Addition of two new pouch sealers.
P100020/S010
9/6/13
COBAS® HPV TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change rooms for positive control formulation and filling.
P100020/S011
9/12/13
COBAS® HPV TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites
P100021/S028
9/12/13
Endurant Stent Graft System, Endurant II Stent Graft System, and Endurant II Aorto-Uni-Iliac Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Alternate second tier-supplier of polyester yarn and ability to use the material from all polyester graft material suppliers for any of the stent-graft configurations.
P100023/S077
9/27/13
ION™ Paclitaxei-Eiuting Coronary Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P100034/S006
9/19/13
NovoTTF-100A SystemNovocure Ltd.
Haifa, Israel
31905
Change to the manufacturing production flow to include distribution logistics that will be performed by Novocure GmbH in Root Luzern, Switzerland.
P100041/S038
9/20/13
Edwards Sapien Transcatheter Heart Valve and Transfemoral AccessoriesEdwards Lifesciences, LLC
Irvine, CA
92614
Update to the tissue fixation system using a new automated process.
P100044/S011
9/18/13
Propel and Propel Mini Sinus ImplantIntersect ENT
Menlo Park, CA
94025
Add a new labeling supplier for the device.
P100047/S029
9/6/13
HeartWare Ventricular Assist SystemHeartWare, Inc.
Miami Lakes, FL 33014
Replacement of the current sterilization process challenge device with an alternative process challenge device for monitoring of ethylene oxide sterilized components of the device.
P110010/S059
9/17/13
PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary StentBoston Scientific Corporation
Maple Grove, MN 55311
Use of an alternate mid-shaft bonding process in the manufacture of the Promus Element Plus stent delivery catheter.
P110010/S060
9/27/13
PROMUS Element™ Plus Everolimus-Eiuting Platinum Chromium Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P110011/S004
9/18/13
Assurant Cobalt Iliac Balloon-Expandable Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the labeling inspection process.
P110013/S025
9/18/13
Resolute Integrity Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the labeling inspection process.
P110016/S009
9/27/13
Therapy Cool Path Duo and Safire Blu Duo Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Additional sterilization chamber for the Therapy Series Ablation Catheters.
P110019/S052
9/13/13
XIENCE XPEDITION™ Everolimus Eluting Coronary Stent Systems (EECS) (XIENCE
XPEDITION RX, XIENCE XPEDITION Small Vessel (SV) RX and XIENCE
XPEDITION Long Lengths (LL) RX)
Abbott Vascular, Inc.
Temecula, CA 92590
Addition of an alternate supplier for the proximal shaft assembly.
P110020/S008
9/6/13
COBAS® 4800 BRAF V600 Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change rooms for positive control formulation and filling.
P110020/S009
9/12/13
COBAS® 4800 BRAF V600 Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites
P110021/S025
9/20/13
Edwards Sapien Transcatheter Heart Valve and Transfemoral and Transapical AccessoriesEdwards Lifesciences, LLC
Irvine, CA
92614
Update to the tissue fixation system using a new automated process.
P110028/S010
9/13/13
Absolute Pro® Vascular Self-Expanding Stent SystemAbbott Vascular, Inc.
Santa Clara, CA 95054
Implement an alternate supplier of the outer member and sheath.
P110035/S019
9/27/13
EpicTM Vascular Self-Expanding Stent SystemBoston Scientific Corporation
Maple Grove MN 55311
Use of new traceability/tracking software in the incoming receiving inspection area.
P110037/S008
9/6/13
COBAS® AmpliPrep/ cobas® TaqMan® CMV TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change rooms for positive control formulation and filling.
P110037/S009
9/12/13
COBAS® AmpliPrep/COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites
P110042/S015
9/25/13
Subcutaneous Implantable Defibrillator (S-ICD®) SystemCameron Health, Inc.
San Clemente, CA 92673
Expand receiving and inspection activities for certain S-ICD® components and accessories to Boston Scientific's facility located in St. Paul, Minnesota.
P120006/S006
9/24/13
Ovation and Ovation Prime Abdominal Stent Graft SystemsTriVascular, Inc.
Santa Rosa, CA 95403
New vendor of the resin material for the molded luer components in the Fill Polymer Kit.
P120019/S002
9/6/13
COBAS® EGFR Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change rooms for positive control formulation and filling.
P120019/S003
9/12/13
COBAS® EGFR Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Refine the current segregation practice for oligonucleotide to allow for more than one batch of oligonucleotide materials at the same time in the manufacturing suites

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 60  

Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 18  
Total On Hold: 34

Summary of PMA Supplements Under Review
Total Under Review: 630
Total Active: 465  
Total On Hold: 165

Summary of All PMA Submissions Received
Originals: 12  
Supplements: 55  

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 60
Number of Denials: 0  
Average Days Fr Receipt to Decision (Total Time): 182.6  
FDA Time: 119.2 Days   MFR Time: 63.4 Days