• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

March 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
P070004
3/9/12
Sientra Silicone Gel Breast Implants (Styles 10512-MP, 10521-HP, 20610-LP, 20621- MP/HP, 20645-LP, 20645-MP/HP, 20646-RB, 20676-E) Sientra, Inc.
Santa Barbara, CA
93117
Approval for the Sientra Silicone Gel Breast Implants. This device is indicated for:
1) Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation as well as revision surgery to correct or improve the result of primary breast augmentation surgery; and
2) Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
P100049
3/22/12
LINX™ Reflux Management System Torax Medical, Inc.
Shoreview, MN
55126
Approval for the LINX™ Reflux Management System. This device is indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum therapy for the treatment of reflux.
P110023
3/7/12
EverFlex Self-Expanding Peripheral Stent System ev3, Inc.
Plymouth, MN
55441
Approval for the EverFlex Self-Expanding Peripheral Stent System. This device is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 180mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 -7.5mm.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18286/S023
3/6/12
Special
Gelfoam (absorbable gelatin) Sterile Sponge Pfizer, Inc
New York, NY
10017
Approval for update on the manufacturing site information and symbols on the labels.
P830055/S124
3/16/12
Real-Time
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of labeling changes to the Instructions for Use (IFU) for various configurations of the device.
P830055/S126
3/30/12
Real-Time
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval to add the Depuy Universal Stem Extensions as compatible components to the previously approved LCS Complete Modular femoral components, LCS Complete Revision femoral components, and MBT tibial trays, and to add the DePuy Universal Femoral Metaphyseal Sleeves as compatible components to the LCS Complete Revision femoral components.
P840062/S022
3/19/12
180-Day
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Integra LifeSciences Corporation
Plainsboro, NJ
08536
Approval for the addition of an additional trade name, OraCote, to the CollaCote Absorbable Collagen Wound Dressing for Dental Surgery product.
P860003/S065
3/2/12
Special
THERAKOS UVAR™ XTS® Photopheresis System THERAKOS, Inc.
Raritan, NJ
08869
Approval for a Technical Bulletin (Technical Bulletin XTS #1) that will be sent out to users of the UVAR™ XTS® Photopheresis System.
P860008/S020
3/6/12
135-Day
Esophageal Pacing System Cardiocommand, Inc.
Tampa, FL
33607
Approval for automating the CNC milling process and the addition of a new inspection molding machine.
P880006/S078
3/21/12
Real-Time
Sensolog/ Dialog/Regency Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 13.1.0 Software for the Model 3650 Merlin Patient Care System to be used with the Sensolog/ Dialog/Regency Family of Pacemakers.
P880086/S217
3/21/12
Real-Time
Affinity/Integrity/ Victory/Zephyr/ Accent Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 13.1.0 Software for the Model 3650 Merlin Patient Care System to be used with the Affinity/ Integrity/Victory/ Zephyr/Accent Family of Pacemakers.
P890003/S245
3/22/12
Real-Time
Medtronic CareLink DDMA, XMLTU Medtronic, Inc.
Mounds View, MN
55112
Approval for a proposed software change pertaining to five Extensible Mark-up Language Translation Utilities (XMLTU) for the following device families: EnTrust, EnRhythm, Revo MRI, Protecta, Concerto and Virtuoso.
P900056/S106
3/1/12
180-Day
Rotoblator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Boston Scientific Corporation located in Heredia, Costa Rica.
P900056/S107
3/23/12
180-Day
Rota Wire Floppy Single and 5pk Rota Wire Ex Support Single and 5pk Wire Clip Torquer 1 Pack and 5 Pack Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P910023/S270
3/9/12
180-Day
Unify, Fortify and Quadra Family of Devices St. Jude Medical, CRMD
Sunnyvale, CA
94086
Approval for the addition of the CorVue Thoracic Impedance Monitoring feature in the Unify, Fortify and Quadra family of devices.
P910023/S293
3/21/12
Real-Time
Cadence/ Current Family of ICDs St. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 13.1.0 Software for the Model 3650 Merlin Patient Care System to be used with the Cadence/ Current Family of ICDs.
P920047/S048
3/23/12
180-Day
Blazer II Cardiac Ablation Cathter; Blazer II HTD Cardiac Ablation Catheter; Blazer Prime HTD Cardiac Ablation Catheter; Sterile Cables Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P940035/S008
3/21/12
180-Day
Alere NMP22® BladderChek® Test, Alere NMP22® BladderChek® Control Kit Alere Scarborough, Inc.
Scarborough, ME
04074
Approval for the intent to manufacture the NMP22® BladderChek® Test and NMP22® BladderChek® Control Kit under Alere Scarborough, Inc. brand name. The devices, as modified, will be marketed under the following trade name: Alere NMP22® BladderChek® Test, with the following Intended Use: The Alere NMP22® BladderChek® Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA), which is an abundant component of the nuclear matrix proteins, in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. This test is indicated for professional use and prescription home use as an aid in diagnosing and monitoring bladder cancer patients, in conjunction with standard diagnostic procedures. Alere NMP22® BladderChek® Control Kit, with the following Intended Use: Alere NMP22® BladderChek® Control Kit is designed to provide the users of the Alere NMP22® BladderChek® Test with additional, optional, quality controls for operating the Test.
P950009/S014
3/9/12
Real-Time
BD FocalPoint™ Slide Profiler TriPath Imaging, Inc.
Durham, NC
27703
Approval for updating the Field of View (FOV) board from version 2 to version 3.
P950018/S015
3/30/12
Real-Time
PERFLUORON® (purified perfluoro-n-octane liquid) Alcon Laboratories
Fort Worth, TX
76134
Approval for minor labeling changes to the approved secondary label lid and to implement an alternate secondary printing operation associated with the implementation of these minor labeling changes.
P950023/S052
3/15/12
Real-Time
Application Software Version PSW 1101.U/1 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the programmer application software version (PSW 1101.U1.
P950037/S101
3/23/12
Real-Time
Evia Family of Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for minor hardware modifications to the Evia/Entovis family of pulse generators which includes the Estella/Effecta/Ecuro pulse generators.
P950037/S102
3/29/12
Real-Time
CardioMessenger LLT Biotronik, Inc.
Lake Oswego, OR
97035
Approval for an update to lead-free solder for printed circuit board manufacturing.
P950037/S104
3/15/12
Real-Time
Application Software Version PSW 1101.U/1 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the programmer application software version (PSW 1101.U1.
P960040/S252
3/15/12
Real-Time
Punctua, Energen and Incepta ICD Boston Scientific
St Paul, MN
55112
Approval for minor design changes and associated manufacturing changes to the PUNCTUA/ INCEPTA/ ENERGEN hybrid assembly.
P960058/S093
3/12/12
180-Day
Auria Harmony HiResolution Bionic Ear System Advanced Bionics, LLC
Sylmar, CA
91324
Approval of an optional noise reduction algorithm called ClearVoice. ClearVoice is a modified version of the approved Fidelity 120 sound processing strategy.
P970013/S047
3/21/12
Real-Time
Microny Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 13.1.0 Software for the Model 3650 Merlin Patient Care System to be used with the Microny Family of Pacemakers.
P970051/S064
3/26/12
180-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for the addition of a modified straight electrode array to the approved CI24RE implant referred to as CI422.
P980003/S030
3/23/12
180-Day
Chilli Cooled Ablation System; Sterile Cables Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P980016/S340
3/22/12
Real-Time
Entrust/Virtuoso/ Protecta Medtronic, Inc.
Mounds View, MN
55112
Approval for a proposed software change pertaining to five Extensible Mark-up Language Translation Utilities (XMLTU) for the following device families: EnTrust, EnRhythm, Revo MRI, Protecta, Concerto and Virtuoso.
P980022/S104
3/28/12
180-Day
Paradigm REAL-Time Revel System, Paradigm REAL-Time System, and Guardian REAL-Time Continuous Monitoring System Medtronic MiniMed
Northridge, CA
91325
Approval to:
1) add the Bayer Contour LINK Wireless Meter to the list of meters, in the labeling, that can communicate with the Paradigm REAL-Time Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K);
2) add the Bayer Contour NEXT LINK Wireless Meter to the list of meters , in the labeling, that can communicate with the Paradigm REAL-Time Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K), Paradigm REAL-Time System (MMT-522, MMT-722, MMT-522K, MMT-722K), and the Guardian REAL-Time Continuous Monitoring System (CSS7100, CSS7100K); and
3) enable the Bayer Contour NEXT LINK Wireless Meter to facilitate transfer of data from the Paradigm REAL-Time Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K), Paradigm REAL-Time System (MMT-522, MMT -722, MMT -522K, MMT -722K}, and the Guardian REAL-Time Continuous Monitoring System (CSS7100, CSS7100K) to the CareLink Therapy Management Software (MMT-7333, MMT-7335) via the meter USB port.
P980022/S108
3/30/12
135-Day
Continuous Subcutaneous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325
Approval for an alternative super capacitor used on the Interface board of the Paradigm REAL-Time Insulin Pump (Models MMT-522, -522K, -722, -722K) and Paradigm REAL-time Revel Insulin pump (Models MMT-523, -523K, -723, -723K) which are components of the Continuous Subcutaneous Glucose Monitoring System.
P980022/S111
3/14/12
Special
iPro2 Continuous Glucose Monitoring System (CGMS) Medtronic MiniMed
Northridge, CA
91325
Approval for labeling changes for updating of cleaning and disinfection methods for multi-patient use for the Sen-Serter component of the device.
P980035/S261
3/22/12
Real-Time
EnRhythm Medtronic, Inc.
Mounds View, MN
55112
Approval for a proposed software change pertaining to five Extensible Mark-up Language Translation Utilities (XMLTU) for the following device families: EnTrust, EnRhythm, Revo MRI, Protecta, Concerto and Virtuoso.
P990012/S012
3/19/12
180-Day
Elecsys HBsAg Immunoassay, Elecsys HBsAg Confirmatory Test Roche Diagnostics
Indianapolis, IN
46250
Approval for the extension of the Elecsys HBsAg Immunoassay and Elecsys HBsAg Confirmatory test onto the cobas e 602 immunoassay analyzer.
P000009/S048
3/15/12
Real-Time
Application Software Version PSW 1101.U/1 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the programmer application software version (PSW 1101.U1.
P000025/S060
3/5/12
Real-Time
MED-EL COMBI 40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713
Approval for a change in the tolerance limits for the OPUS 1 speech processor frequency measurement during final inspection of the device. The reason for the change in the tolerance limits was a change in the OPUS 1 microphone from the original microphone Knowles EG-3000-CX to the Knowles EG-23000-CX.
P000046/S015
3/27/12
180-Day
Staarvisc® II, Shellgel™, Optivisc™ and Anikavisc™ Sodium Hyaluronate Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for a manufacturing site change from the previous facility located in Woburn, Massachusetts to the new facility located in Bedford, Massachusetts. In addition, the supplement requested approval to change the terminal sterilization method of the product from e-beam controlled depth sterilization to vaporized hydrogen peroxide (VHP) gas sterilization.
P000053/S040
3/9/12
Real-Time
AMS Sphincter 800® Urinary Prosthesis American Medical Systems, Inc.
Minnetonka, MN
55343
Approval for minor changes to several dimensional tolerances of the balloon adaptor subcomponent.
P010003/S016
3/5/12
Real-Time
EASYRAK 3 IS-1 Boston Scientific Corporation
St. Paul, MN
55112
Approval for the following changes:
1) addition of Optinova as supplier of extruded polyurethane tubing;
2) modification to dimensional tolerances for extruded polyurethane tubing;
3) modification to polyurethane tubing specification for foreign material, bubbles, and gel inclusions; and
4) removal of redundant Methylene Dianiline (MDA) residual level requirements for extruded tubing.
P010012/S282
3/15/12
Real-Time
Punctua, Energen and Incepta CRT-D Boston Scientific
St. Paul, MN
55112
Approval for minor design changes and associated manufacturing changes to the PUNCTUA/ INCEPTA/ENERGEN hybrid assembly.
P010031/S293
3/22/12
Real-Time
Concerto/Protecta Medtronic, Inc.
Mounds View, MN
55112
Approval for a proposed software change pertaining to five Extensible Mark-up Language Translation Utilities (XMLTU) for the following device families: EnTrust, EnRhythm, Revo MRI, Protecta, Concerto and Virtuoso.
P010047/S015
3/19/12
180-Day
NeoMend ProGel Pleural Air Leak Sealant NeoMend, Inc.
Irvine, CA
92618
Approval of the post-approval study protocol.
P010047/S016
3/23/12
Real-Time
NeoMend ProGel Pleural Air Leak Sealant NeoMend, Inc.
Irvine, CA
92618
Approval for an extension of shelf life of the ProGEL Extended Applicator Spray Tips from 12 to 24 months. The device, as modified, will be marketed under the trade name ProGEL Extended Applicator Spray Tips and is indicated to deliver ProGEL to visceral pleura during an open thoracotomy after standard visceral pleural closure (i.e. with sutures or staples) of visible air leaks (≥ 2 mm) incurred during open resection of lung parenchyma in adult humans by bending the malleable tip to direct ProGEL from the delivery tip in a stream or spray cone pattern that is perpendicular to the target surface.
P010050/S015
3/27/12
135-Day
IMMULITE/ IMMULITE 1000 & IMMULITE 2000 HBsAg and IMMULITE/ IMMULITE 1000 & IMMULITE 2000 HBsAg Confirmatory Siemens Healthcare Diagnostics
E. Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P010051/S011
3/27/12
135-Day
IMMULITE/ IMMULITE 1000 & IMMULITE 2000 Anti-HBc Siemens Healthcare Diagnostics
E. Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P010052/S011
3/27/12
135-Day
IMMULITE/ IMMULITE 1000 & IMMULITE 2000 Anti-HBs Siemens Healthcare Diagnostics
E. Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P010053/S010
3/27/12
135-Day
IMMULITE/ IMMULITE 1000 & IMMULITE 2000 Anti-HBc IgM Siemens Healthcare Diagnostics
E. Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P020004/S070
3/16/12
Real-Time
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for an alternate fluorinated ethylene propylene (FEP) resin and an alternate supplier for the FEP film. The supplement also requested approval for a change to the specifications of the FEP film. The devices, as modified, will be marketed under the same trade name identified.
P020009/S075
3/23/12
180-Day
Express 2 Monorail and OTW Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P020014/S035
3/19/12
180-Day
Essure System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Approval for revised professional and patient labeling.
P020025/S029
3/23/12
180-Day
Blazer II XP Cardiac Ablation Catheter; Blazer Prime XP Cardiac Ablation Catheter; Blazer CP RPM Cardiac Ablation Catheter; Sterile Cables Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P020027/S017
3/22/12
Real-Time
Dimension® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for a software revision that changes the operating system of the instrument from the current QNX operating system to the Linux operating system and addresses hardware obsolescence issues.
P020030/S007
3/15/12
135-Day
Stelid II BTF/BJF Steroid Collar ELA Medical, Inc.
Plymouth, MN
55441
Approval for improving the steroid collar manufacturing process.
P030023/S002
3/12/12
135-Day
Ophtec-Stableyes Capsular Tension Ring OPHTEC USA, Incorporated
Boca Raton, FL
33487
Approval for a new supplier of a critical raw material.
P030031/S038
3/23/12
Real-Time
ThermoCool SF Nav Bi-directional catheter; ThermoCool SF Bi-directional catheter; ThermoCool SF Uni-directional catheter and ThermoCool SF Nav Uni-directional catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for extending the shelf life for the catheters referenced from one to three years.
P030035/S095
3/21/12
Real-Time
Frontier/Frontier IV; Anthem Family of CRT-Ps St. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 13.1.0 Software for the Model 3650 Merlin Patient Care System to be used with Frontier/ Frontier IV; Anthem Family of CRT-Ps.
P030050/S011
3/22/12
135-Day
Sculptra (Injectable poly-L-lactic acid) Sanofi Aventis
Bridgewater, NJ
08807
Approval for the addition of an alternate supplier for an ingredient used in the manufacture of Sculptra.
P030054/S196
3/9/12
180-Day
Unify, Fortify and Quadra Family of Devices St. Jude Medical, CRMD
Sunnyvale, CA
94086
Approval for the addition of the CorVue Thoracic Impedance Monitoring feature in the Unify, Fortify and Quadra family of devices.
P030054/S214
3/23/12
180-Day
Veriflex Monorail and OTW Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P030054/S220
3/21/12
Real-Time
Epic HF/Atlas+ HF/Promote Family of CRT-Ds St. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 13.1.0 Software for the Model 3650 Merlin Patient Care System to be used with the Epic HF/Atlas+ HF/Promote Family of CRT-Ds.
P040012/S042
3/29/12
180-Day
RX Acculink Carotid Stent System Abbott Vascular
Santa Clara, CA
95054
Approval for addition of the Emboshield family of embolic protection systems (EPS) to the standard risk indication and an update to the magnetic resonance compatibility section of the labeling.
P040016/S073
3/23/12
180-Day
Veriflex Monorail and OTW Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P040023/S018
3/8/12
Real-Time
DePuy Duraloc Option Ceramic on Ceramic Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for labeling changes to the Instructions for Use for the Duraloc Option Ceramic Hip System.
P040025/S012
3/27/12
Real-Time
Olympic Cool-Cap® Natus Medical Incorporated
Seattle, WA
98108
Approval for a redesigned printed circuit board (the SysCAM PCB, previously PN 401339 and now PN 002819), for the device.
P040043/S045
3/16/12
Real-Time
GORE® TAG® THORACIC Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for an alternate fluorinated ethylene propylene (FEP) resin and an alternate supplier for the FEP film. The supplement also requested approval for a change to the specifications of the FEP film. The devices, as modified, will be marketed under the same trade name identified.
P050012/S044
3/8/12
Real-Time
Dexcom SEVEN® PLUS Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121
Approval for a firmware modification to the Receiver component of the device in order to increase the tone and duration of user alerts and alarms.
P050023/S049
3/29/12
Real-Time
CardioMessenger II-S Biotronik, Inc.
Lake Oswego, OR
97035
Approval for an update to lead-free solder for printed circuit board manufacturing.
P050023/S050
3/29/12
Real-Time
Lumax Family ICD and CRT-D Biotronik, Inc.
Lake Oswego, OR
97035
Approval for an adapter for the high voltage capacitor and feedthrough.
P050023/S052
3/15/12
Real-Time
Application Software Version PSW 1101.U/1 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the programmer application software version (PSW 1101.U1.
P050028/S020
3/20/12
180-Day
COBAS AmpliPrep/ COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for Use with the High Pure System Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for changes to the assay instrumentation and software platform collectively referred to as the CAP/CTM Second Generation System.
P050033/S013
3/9/12
180-Day
Hydrelle™ Anika Therapeutics Inc.
Bedford, MA
01730
Approval for updates to the approved product label based on the results of the post-approval clinical study.
P050033/S014
3/20/12
Special
Hydrelle Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for addition of new safety information to the product label.
P050037/S026
3/14/12
180-Day
Radiesse Injectable Implant Merz Aesthetics
Franksville, WI
53126
Approval for a manufacturing site located in Sturtevant, Wisconsin.
P050037/S027
3/14/12
180-Day
Radiesse Injectable Implant Merz Aesthetics
Franksville, WI
53126
Approval for a manufacturing site located in Sturtevant, Wisconsin.
P050046/S012
3/5/12
Real-Time
ACUITY Steerable IS-1 Boston Scientific
St. Paul, MN
55112
Approval for the following changes:
1) addition of Optinova as supplier of extruded polyurethane tubing;
2) modification to dimensional tolerances for extruded polyurethane tubing;
3) modification to polyurethane tubing specification for foreign material, bubbles, and gel inclusions; and
4) removal of redundant Methylene Dianiline (MDA) residual level requirements for extruded tubing.
P050047/S016
3/29/12
135-Day
Juvèderm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Approval for the proposed change in the intermediate HA concentration during product manufacture.
P050052/S029
3/14/12
180-Day
Radiesse Injectable Implant Merz Aesthetics
Franksville, WI
53126
Approval for a manufacturing site located in Sturtevant, Wisconsin.
P050052/030
3/14/12
180-Day
Radiesse Injectable Implant Merz Aesthetics
Franksville, WI
53126
Approval for a manufacturing site located in Sturtevant, Wisconsin.
P060006/S021
3/23/12
180-Day
Express SD Renal MR Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P060008/S072
3/23/12
180-Day
TAXUS Libertè Monorail and OTW Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P060023/S001
3/9/12
180-Day
BRYAN® Cervical Disc Medtronic Sofamor Danek USA, Inc.
Memphs, TN
38132
Approval for a modified surgical technique, new instrumentation, and modified labeling to include information on MRI compatibility of the implanted device.
P060030/S021
3/20/12
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 changes to the assay instrumentation and software platform collectively referred to as the CAP/CTM Second Generation System.
P060035/S011
3/2/12
135-Day
ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL
60064
Approval for a modification to the bioburden test.
P060040/S016
3/29/12
Special
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA
94588
Approval for providing additional information in the labeling regarding proper engagement of the bend relief with the sealed outflow graft of the device at the time of implant.
P070007/S034
3/5/12
Special
Talent Captivia Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval for labeling changes and a change in the graft loading process.
P070008/S030
3/15/12
Real-Time
Application Software Version PSW 1101.U/1 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the programmer application software version PSW 1101.U1.
P070015/S082
3/13/12
180-Day
Xience™ nano Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Approval for extending the shelf life from 12 months to 24 months for the device.
P070022/S025
3/20/12
180-Day
Adiana Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752
Approval for modifications of the Adiana RF generator to incorporate a touch screen user interface.
P080023/S011
3/2/12
135-Day
ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064
Approval for a modification to the bioburden test.
P090013/S054
3/22/12
Real-Time
Revo MRI Medtronic, Inc.
Mounds View, MN
55112
Approval for a proposed software change pertaining to five Extensible Mark-up Language Translation Utilities (XMLTU) for the following device families: EnTrust, EnRhythm, Revo MRI, Protecta, Concerto and Virtuoso.
P100018/S004
3/22/12
180-Day
Pipeline® Embolization Device Micro Therapeutics, Inc.
Irvine, CA
92613
Approval for a manufacturing site located at ev3 Neurovascular, Irvine, California as an additional manufacturing site for the device.
P100023/S005
3/23/12
180-Day
ION Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for a manufacturing site located at Isotron Netherland BV, Venlo, the Netherlands.
P100041/S006
3/20/12
Real-Time
Edwards SAPIEN™ Transcatheter Heart Valve, RetroFlex™ Balloon Catheter and Crimper Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for use of a previously approved alternate material for the flush tube.
P110003/S001
3/1/12
135-Day
LeGoo Endovascular Occluder Pluromed, Inc.
Woburn, MA
01801
Approval for a change to a sterilization process parameter.

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
N18033/S064
3/26/12
VISTAKON (etafilcon A)Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use an alternate process for removing the back curve plastic mold from the cured lens during manufacturing.
P810002/S081
3/23/12
Mechanical Heart Valve St. Jude Medical, Inc
St. Paul, MN
55117
Eliminating the use of one method for coating thickness image capture and replacing it with a new method.
P820003/S115
3/23/12
Adaptor: EPG Safety Cable Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P830061/S075
3/23/12
CapSure, Vitatron Crystaline, Vitatron Excellence PS+ Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P840064/S050
3/12/12
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Inc.
Fort Worth, TX
76134
Alternate mixer process during manufacturing.
P850089/S087
3/23/12
CapSure, CapSure Z Novus, Vitatron Impulse II Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P860057/S086
3/22/12
Carpentier Edwards Perimount Pericardial Endoprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Add an alternate supplier for cap components.
P870056/S046
3/22/12
Carpentier Edwards Perimount Pericardial Endoprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Add an alternate supplier for cap components.
P870077/S042
3/22/12
Carpentier Edwards Perimount Pericardial Endoprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Add an alternate supplier for cap components.
P890003/S246
3/23/12
CapSure, CapSure Model, Prodigy, Service Kit-Pacemaker Repair Kit Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P890047/S038
3/12/12
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Inc.
Fort Worth, TX
76134
Alternate mixer process during manufacturing.
P900060/S048
3/7/12
Carbomedics Prosthetic Heart Valve Sorin Group USA, Inc.
Arvada, CO
80004
Modification to the labeling algorithm.
P900061/S112
3/23/12
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, Ace header, Defibrillation support device, Lead end pin cap, Oval Patch Lead Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P910007/S034
3/22/12
ARCHITECT TOTAL PSA Abbott Laboratories
Abbott Park, IL
60064
Addition of an absorbance test to confirm Abbott’s claim of 70% detergent (Triton X-405) concentration to verify conformance of incoming product.
P910023/S288
3/12/12
Epic/+/II/II+, Current Fortify Family of Devices St. Jude Medical
Sylmar, CA
91342
Change to the receiving inspection sample size for a component.
P910023/S289
3/14/12
Fortify Family of ICDs St. Jude Medical
Sylmar, CA
91342
Acceptance of optimized bond parameters used in the hybrid wire bonding process.
P920015/S086
3/21/12
Sprint Quattro Secure DF4 Lead Medtronic, Inc.
Mounds View, MN
55112
Add Sprint Quattro Secure Lead Model 6974M to previously approved 30-Day Notice submissions regarding sterile packaging process changes.
P920015/S087
3/26/12
Sprint Quattro Secure DF4 Lead Medtronic, Inc.
Mounds View, MN
55112
Add automation to the lead assembly process.
P920015/S088
3/23/12
"Y" adaptor/ extender kit, DF-1 connector port pin plug, IS-I Connector Port Pin plug kit, Lead adaptor, Sprint Quattro, Sprint Quattro lead, Subcutaneous Lead, Transvene SVC lead, Tunneling tool Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P930014/S059
3/15/12
AcrySof Alcon Research, Ltd.
Fort Worth, TX
76134
Elimination of the In-Process Quality Test for Refractive Index.
P930029/S036
3/23/12
Cable ATAKR to ECG, Conductr 5 mm 8fr, Contactr Catheter 7 Fr 5 mm, Contactr Catheter 7 Fr 4 mm, RF Conductr 4 mm Catheter, RF Enhancr II ablation catheter, RF MARINR UNI, RF Marinr MC 7F 5/5/5, RF Marinr MC 7fr 112 Cm, RF Marinr MC 7fr 2-5-2, RF Marinr MC XL 5/5/5, RF Marinr MC XI 7fr, RF Marinr SC SF 80CM, RF Marinr Sc XI 5fr 110 cm. RF Marinr Sc Xs 5fr 110 cm, RF Marinr SCXL 5F 80CM, RF Marinr SCXXL 5F 80CM Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P930039/S066
3/23/12
CapSure, SureFix, TORQUE CLIP DEVICE, Vitatron Crystalline ActFix Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P950020/S049
3/30/12
Coronary Flextome Cutting Balloon Boston Scientific Corporation
Maple Grove, MN
55311
Change to the manufacturing process equipment at the Plymouth facility.
P950024/S041
3/23/12
CapSure Epicardial Pacing Lead Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P950037/S103
3/5/12
Philos DR, DR-B, DR-T, SR & SR-B/Philos II DR, DR-T & SR/Cyclos DR, DR-T & VR/Evia DR, DR-T, SR & SR-T/Entrovis DR, DR-T, SR & SR-T/Estella DR, DR-T, SR & SR-T/Ecuro DR, DR-T, SR & SR-T/Effecta D, DR, S & SR Biotronik, Inc.
Lake Oswego, OR
97035
New laser weld process to weld connection bands to Nickel pads.
P960011/S021
3/30/12
BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) Ferring Pharmaceuticals Incorporated
Parsippany, NJ
07054
Alternate use of a new syringeability machine for QC testing.
P960040/S251
3/1/12
Teligen, Ventak Prizm HE, Vitality, Vitality DS/DS VR/EL, Vitality 2, Vitality AVT and Confient ICDs Boston Scientific Corporation
St. Paul, MN
55112
Addition of a new manufacturing equipment.
P960040/S253
3/30/12
Incepta, Energen and Punctua ICDs Boston Scientific Corporation
St. Paul, MN
55112
Remove an insertion force process monitor.
P960040/S254
3/28/12
Teligen, Incepta, Energen, Punctua ICDs Boston Scientific Corporation
St. Paul, MN
55112
Use of a new insulator tape used in the high voltage capacitor.
P970008/S061
3/13/12
Urologix Targis System for the Treatment of BPH Urologix, Inc.
Minneapolis, MN
55447
Replacement of an obsolete patient cable fiber ST connector used in the manufacture of the Targis System CoolWave Control Units.
P970020/S071
3/7/12
RX ZETA, OTW SETA Abbott Vascular
Temecula, CA
92591
Change to the balloon manufacturing process.
P970020/S073
3/23/12
Multi-Link OTW Ultra and Multi-Link RX Ultra Coronary Stent Systems Abbott Vascular
Temecula, CA
92591
New heat sealer for finished goods packaging.
P980007/S025
3/22/12
ARCHITECT FREE PSA Abbott Laboratories
Abbott Park, IL
60064
Addition of an absorbance test to confirm Abbott’s claim of 70% detergent (Triton X-405) concentration to verify conformance of incoming product.
P980016/S335
3/7/12
Entrust; Intrinsic; Marquis DR; Marquis VR; Maximo OR; Maximo II; Maximo VR; Protecta; Protecta M4; Protecta XT; Protecta XT M4; Secura; Virtuoso; and Virtuoso II ICDs Medtronic, Inc.
Mounds View, MN
55112
Software upgrade to the existing manufacturing equipment.
P980016/S336
3/5/12
Protecta XT/ Protecta/Secura/ Maximo II DR DF4 Medtronic, Inc.
Mounds View, MN
55112
Align the production processes for the devices with those used for approved predecessor products.
P980016/S338
3/9/12
Protecta DR/R, Protecta XT DR/VR Medtronic, Inc.
Mounds View, MN
55112
Add additional models that were not included in a previously approved 30-Day Notice regarding the implementation of Material Analysis and Qualification System (MAQS) for incoming inspection.
P980016/S341
3/23/12
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Maximo II M4, Protecta, Protecta M4, Protecta XT, Protecta XT M4, Secura, Secura M4, Virtuoso, Virtuoso II Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P980022/S109
3/9/12
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time System, CGMS iPro System and iPro2 Professional Continuous GlucoseMonitoring (COM) System LV-1 and IS-1, Acuity Spiral Leads Medtronic MiniMed, Inc.
Northridge, CA
91325
Implementation of a new cleaning system called Isopropyl Alcohol Recirculating Cleaning or IPARC. The IPARC system is used to clean the sensor base and needle assembly components of the SOF-SENSOR™ Glucose Sensor (MMT-7002, MMT-7003). The SOF-SENSOR™ is a component of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time System, CGMS iPro System and iPro2 Professional Continuous Glucose Monitoring (CGM) System.
P980035/S258
3/7/12
Advisa DR and Enrhythm IPGs Medtronic, Inc.
Mounds View, MN
55112
Software upgrade to the existing manufacturing equipment.
P980035/S260
3/9/12
Advisa DR Medtronic, Inc.
Mounds View, MN
55112
Add additional models that were not included in a previously approved 30-Day Notice regarding the implementation of Material Analysis and Qualification System (MAQS) for incoming inspection.
P980035/S262
3/23/12
Adapta, Advisa, EnRhythm, Relia, Sensia, Versa Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P980050/S071
3/23/12
Transvene CS/SVC Lead Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P990001/S101
3/23/12
Vitatron DA+ C-Series IPG, Vitatron DA+ T-Series IPG Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P990012/S014
3/28/12
Elecsys HBsAG Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P990025/S030
3/30/12
EZ Steer NAV Electrophysiology Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Change in calibration and calibration check manufacturing processes PI-008-01 and PI-008-02 to incorporate the Catheter Calibration System as an alternative to the Helmholtz Calibration System.
P990038/S015
3/9/12
ETI-MAK-2 PLUS Assay DiaSorin Incorporated
Stillwater, MN
55082
Change in the QC test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
P990041/S014
3/9/12
ETI-AB-EBK PLUS Assay DiaSorin Incorporated
Stillwater, MN
55082
Change in the QC test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
P990042/S011
3/9/12
ETI-AB-AUK PLUS Assay DiaSorin Incorporated
Stillwater, MN
55082
Change in the QC test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
P990043/S015
3/9/12
ETI-EBK PLUS Assay DiaSorin Incorporated
Stillwater, MN
55082
Change in the QC test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
P990044/S012
3/9/12
ETI-CORE-IGMK PLUS Assay DiaSorin Incorporated
Stillwater, MN
55082
Change in the QC test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
P990045/S012
3/9/12
ETI-AB-COREK PLUS Assay DiaSorin Incorporated
Stillwater, MN
55082
Change in the QC test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.
P990056/S017
3/28/12
Elecsys Total PSA Roche Diagnostics
Indianapolis, IN
46250
Change to transfer the rework location from Building R to a connected building W2, on the Indianapolis campus for the device.
P000007/S029
3/22/12
Carpentier Edwards Perimount Pericardial Endoprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Add an alternate supplier for cap components.
P000014/S025
3/13/12
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
1) Changing the timings of the QA release test from sequential to concurrent described as the Single-Test; and
2) Reducing the number of the assays in the MGCC release test.
P000021/S022
3/16/12
Dimension TPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Discontinuation of an absorbance test performed on Nylon-Surlyn film and Surlyn film prior to release of the film for slitting and cuvette film canister assembly.
P000025/S061
3/28/12
MED-EL COMBI 40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713
Use of new silicone mixing equipment.
P000027/S015
3/28/12
Elecsys Free PSA Roche Diagnostics
Indianapolis, IN
46250
Transfer the rework location from Building R to a connected Building W2 on the Indianapolis campus for the device.
P000054/S029
3/15/12
Infuse Bone Graft/ LT-Cage Lumbar Tapered Fusion, Infuse Bone Graft Medtronic Sofamor Danek USA, Inc.
Memphis, TN
38132
Change to drug testing by one of the contract manufacturers.
P000058/S042
3/15/12
Infuse Bone Graft/ LT-Cage Lumbar Tapered Fusion, Infuse Bone Graft Medtronic Sofamor Danek USA, Inc.
Memphis, TN
38132
Change to drug testing by one of the contract manufacturers.
P010012/S281
3/1/12
Cognis, Contak Renewal 3, Contak Renewal 3 HE and Livian CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Addition of a new manufacturing equipment.
P010012/S283
3/30/12
Incepta, Energen and Punctua CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Remove an insertion force process monitor.
P010012/S284
3/28/12
Cognis, Incepta, Energen, Punctua CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Use of a new insulator tape used in the high voltage capacitor.
P010015/S154
3/9/12
Consulta, Syncra Medtronic, Inc.
Mounds View, MN
55112
Add additional models that were not included in a previously approved 30-Day Notice regarding the implementation of Material Analysis and Qualification System (MAQS) for incoming inspection.
P010015/S155
3/23/12
Attain, Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P010019/S029
3/2/12
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear CIBA VISION Corporation
Duluth, GA
30097
Raw Material Test Method Changes.
P010027/S004
3/2/12
AMO DuraLens II UV-Absorbing PMAA Anterior Chamber Intraocular Lens Aaren Scientific, Inc.
Ontario, CA
91761
Alternate vendor to perform Limulus Amebocyte Lysate (LAL) testing.
P010027/S005
3/2/12
Optical Testing Laboratory (OTL) Aaren Scientific, Inc.
Ontario, CA
91761
Installation of an Optical Testing Laboratory Optical Bench.
P010029/S014
3/30/12
EUFLEXXA (1% Sodium Hyalronate) Ferring Pharmaceuticals Incorporated
Parsippany, NJ
07054
Alternate use of a new syringeability machine for QC testing.
P010031/S288
3/7/12
Concerto ICD; Concerto II CRT-D; Consulta CRT-D and; InSync III Marquis CRT-D; InSync Maximo CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta M4 CRT-D; Protecta XT CRT-D; and Protecta XT M4 CRT-D Medtronic, Inc.
Mounds View, CA
55112
Software upgrade to the existing manufacturing equipment.
P010031/S289
3/5/12
Protecta XT/ Protecta/Consulta/ Maximo II CRT-D DF4 Medtronic, Inc.
Mounds View, MN
55112
Align the production processes for the devices with those used for approved predecessor products.
P010031/S291
3/9/12
Protecta CRT-D, Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
Add additional models that were not included in a previously approved 30-Day Notice regarding the implementation of Material Analysis and Qualification System (MAQS) for incoming inspection.
P010031/S294
3/23/12
Concerto, Concerto II, Consulta, Consulta DF4, InSync III Marquis, InSync Maximo, Maximo II, Maximo II M4, Protecta, Protecta M4, Protecta XT, Protecta XT M4 Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P010032/S047
3/2/12
Eon™ Rechargeable IPG System St. Jude Medical
Plano, TX
75024
Modification to the acceptance criteria for the charging antenna and portable charging antenna.
P010041/S031
3/22/12
Carpentier Edwards Perimount Pericardial Endoprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Add an alternate supplier for cap components.
P010047/S017
3/1/12
Progel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Implement an automated UV bonding system to build extended tips.
P010054/S019
3/28/12
Elecsys Anti-HBs Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P010068/S026
3/30/12
Navistar DS Electrophysiology Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Change in calibration and calibration check manufacturing processes PI-008-01 and PI-008-02 to incorporate the Catheter Calibration System as an alternative to the Helmholtz Calibration System.
P020009/S081
3/2/12
Express2 Monorail and Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the balloon drying process.
P020016/S006
3/15/12
Total Temporomandibular Joint Replacement System Biomet Microfixation
Jacksonville, FL
32218
Change in the cleaning detergent, a change in the machining oil and a manufacturing program change.
P020027/S018
3/16/12
Dimension FPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Discontinuation of an absorbance test performed on Nylon-Surlyn film and Surlyn film prior to release of the film for slitting and cuvette film canister assembly.
P020036/S023
3/22/12
SMART Nitinol Stent System and SMART Control Nitinol Stent System Cordis Corporation
Miami Lakes, FL
33014
Package handling change to the heat sealing process.
P020047/S043
3/7/12
VISION RX, VISION OTW MINI VISION RX, MINI VISION OTW Abbott Vascular
Temecula, CA
92591
Change to the balloon manufacturing process.
P020047/S047
3/23/12
Multi-Link 8 Coronary Stent System Abbott Vascular
Temecula, CA
92591
New heat sealer for finished goods packaging.
P030017/S129
3/9/12
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Changes to the battery profile download software for the device.
P030031/S040
3/30/12
EZ Steer Thermocool NAV Catheter, NAVI-STAR Electrophysiology Catheter & Thermocool SF NAV Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Change in calibration and calibration check manufacturing processes PI-008-01 and PI-008-02 to incorporate the Catheter Calibration System as an alternative to the Helmholtz Calibration System
P030036/S041
3/23/12
Anchoring Sleeve Kit, SelectSecure Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P030047/S024
3/22/12
PRECISE RX and PRECISE PRO Rx Nitinol Stent Systems Cordis Corporation
Miami Lakes, FL
33014
Package handling change to the heat sealing process.
P030054/S215
3/12/12
Atlas/Epic/HF/HF+, Promote, Unify Family of Devices St. Jude Medical
Sylmar, CA
91342
Change to the receiving inspection sample size for a component.
P030054/S216
3/14/12
Unity Family of CRT-Ds St. Jude Medical
Sylmar, CA
91342
Acceptance of optimized bond parameters used in the hybrid wire bonding process.
P040016/S084
3/2/12
VeriFLEX (Libertè) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the balloon drying process.
P040020/S040
3/12/12
AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX
76134
Elimination of the In-Process Quality Test for Refractive Index.
P040036/S029
3/30/12
EZ Steer Thermocool NAV Catheter, NAVI-Star Electrophysiology Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Change in calibration and calibration check manufacturing processes PI-008-01 and PI-008-02 to incorporate the Catheter Calibration System as an alternative to the Helmholtz Calibration System
P040045/S032
3/21/12
VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use of an alternate process for de-ionized water removal during manufacturing.
P050023/S051
3/5/12
Lumax 300 DR-T, VR-T & HF-T/Lumax 340 DR-T, VR-T & HF-T/Lumax 500 DR-T, VR-T & HF-T/Lumax 540 DR-T, VR-T, VR-T DX & HF-T Biotronik, Inc.
Lake Oswego, OR
97035
New laser weld process to weld connection bands to Nickel pads.
P050038/S011
3/23/12
ARISTA AH Absorbable Hemostat Medafor, Inc.
Minneapolis, MN
55430
Addition of an alternate supplier of a critical component used in the manufacture of the ARISTA AH Absorbable Hemostat.
P050047/S023
3/20/12
Juvèderm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Approval of two changes:
1) addition of a waiting period while the gel is sitting in the mobile tank and;
2) an environmental change in the secondary packaging room of the Pringy I manufacturing facility.
P050049/S010
3/1/12
AxSYM HBsAg, HBsAg Confirmatory and AxSYM HBsAg Controls Abbott Laboratories
Abbott Park, IL
60064
Change to the two microbial testing methods for bioburden and sterility determination for code 37199 and 97218.
P050053/S020
3/15/12
Infuse Bone Graft/ LT-Cage Lumbar Tapered Fusion, Infuse Bone Graft Medtronic Sofamor Danek USA, Inc.
Memphis, TN
38132
Change to drug testing by one of the contract manufacturers.
P060006/S024
3/2/12
Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the balloon drying process.
P060008/S085
3/2/12
TAXUS Libertè Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the balloon drying process.
P060011/S003
3/8/12
C-flex Intraocular Lens and C-flex Aspheric Intraocular Lens Rayner Intraocular Lenses Limited
Hove, East Sussex, England
BN3 7AN
Software upgrade to the optical measuring equipment.
P060038/S011
3/19/12
Mitroflow Aortic Pericardial Heart Valve Sorin Group USA, Inc.
Arvada, CO
80004
Change a critical component supplier.
P060039/S034
3/23/12
Attain StarFix Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P070008/S029
3/5/12
Stratos LV & LV-T Biotronik, Inc.
Lake Oswego, OR
97035
New laser weld process to weld connection bands to Nickel pads.
P070015/S089
3/2/12
XIENCE V and XIENCE nano Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92590
Equipment upgrade for use in the stent retention process.
P070015/S090
3/7/12
XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92590
Change to the balloon manufacturing process.
P070015/S091
3/22/12
XIENCE V, XIENCE nano and PROMUS Everolimus-Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92590
Extension of stability testing for a copolymer used in the drug formulation of the devices.
P070022/S028
3/28/12
Adiana Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752
Minor changes to the manufacturing procedure of the catheter tip for the device.
P070022/S029
3/30/12
Adiana Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752
Changes implemented in ECO-20575.
P080006/S038
3/9/12
Attain Ability Plus, Attain Ability Straight Medtronic, Inc.
Mounds View, MN
55112
Add additional models that were not included in a previously approved 30-Day Notice regarding the implementation of Material Analysis and Qualification System (MAQS) for incoming inspection.
P080006/S039
3/16/12
Attain Ability Leads Medtronic, Inc.
Mounds View, MN
55112
Change to the laser ablation process.
P080006/S040
3/23/12
Attain Ability, Attain Ability Plus, Attain Ability Straight Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P080032/S008
3/22/12
Alair Bronchial Thermoplasty System Boston Scientific Corporation
Sunnyvale, CA
94089
Process changes related to the Alair Catheter Model as well as the Alair Radiofrequency Controller.
P090007/S008
3/28/12
Elecsys Anti- HCV on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P090008/S009
3/28/12
Elecsys Anti-HCV on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P090009/S008
3/28/12
Elecsys Anti-HCV on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P090013/S051
3/7/12
Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
Software upgrade to the existing manufacturing equipment.
P090013/S053
3/9/12
REVO MRI SureScan Medtronic, Inc.
Mounds View, MN
55112
Add additional models that were not included in a previously approved 30-Day Notice regarding the implementation of Material Analysis and Qualification System (MAQS) for incoming inspection.
P090013/S055
3/22/12
CapSure Fix Lead, Revo MRI Medtronic, Inc.
Mounds View, MN
55112
Updates to the software used to direct and track manufacturing activities.
P100023/S035
3/2/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the balloon drying process.
P100023/S036
3/9/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of a catheter manifold molding line at the Galway manufacturing facility.
P100031/S006
3/28/12
Elecsys Anti-HBc on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P100032/S006
3/28/12
Elecsys Anti-HBc on Elecsys 2010 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P100041/S007
3/22/12
Edwards SAPIEN Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Add an alternate supplier for cap components.
P110010/S007
3/9/12
Promus Element Plus Everolimus- Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of a catheter manifold molding line at the Galway manufacturing facility.
P110019/S012
3/2/12
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Equipment upgrade for use in the stent retention process.
P110019/S013
3/7/12
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Removal of an inspection step.
P110019/S015
3/22/12
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc
Temecula, CA
92591
Extension of stability testing for a copolymer used in the drug formulation of the devices.
P110022/S006
3/28/12
Elecsys Anti-HBc IGM on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P110025/S006
3/28/12
Elecsys Anti-HBc IgM on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.
P110031/S006
3/28/12
Elecsys Anti-HBc IgM on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250
Transfer of the rework activities for the Elecsys reagent kits from Building R to Building W2 on the Indianapolis campus.

Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 92

Summary of PMA Originals Under Review
Total Under Review: 70
Total Active: 27
Total On Hold: 43
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 649
Total Active: 488
Total On Hold: 161
Number Greater Than 180 Days: 7

Summary of All PMA Submissions Received
Originals: 2
Supplements: 105

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 92
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 155.6
FDA Time: 132.3 Days MFR Time: 23.3 Days