Advertisement
News
Advertisement

PMA Final Decisions for March 2011

Fri, 04/29/2011 - 11:30am
U.S. Food & Drug Administration

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.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P080020

3/22/11

Gel-One Seikagaku Corporation

Tokyo, Japan

100-0005

Approval for the Gel-One™. The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics, e.g., acetaminophen.
P080025

3/14/11

Medtronic® InterStim® Therapy System Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for the Medtronic® InterStim® Therapy System. The device is indicated for the treatment of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18033/S048

3/10/11

135-Day

VISTAKON (etafilconA) Contact Lens Johnson & Johnson Vision Care, Inc.

Jacksonville, FL 32256

Approval to implement an alternate method for re-sampling lenses.
P830055/S115

3/11/11

135-Day

LCS Complete Total Knee System DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for: 1) automating all milling/grinding processes that were previously manual; 2) use of an oil-based coolant during milling/ grinding; and 3) including a new process – manual in-process clean (IPC) to remove the oil-based coolant after milling.
P840001/S102

3/15/11

Real-Time

Restore Implantable Neurostimulators Medtronic Neurological

Minneapolis, MN

55432

Approval for minor firmware change.
P850007/S031

3/11/11

Real-Time

Spinal-Stim Orthofix, Inc.

Lewisville, TX

75056

Approval for design modifications to the garment covering, the treatment coils, liquid crystal display, control unit housing profile, orientation of the controls, software/ firmware, power supply cord, and labeling. The device, as modified, will be marketed under the trade name Spinal-Stim and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a non-operative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
P860004/S138

3/3/11

135-Day

SynchroMed II Infusion System Medtronic Neuromodulation

Minneapolis, MN

55432

Approval of the following manufacturing process changes related to the Baseline test of the Implantable SynchroMed II Infusion Pump, Model 8637: 1) automation of the transfer of baseline test data; 2) change the duty cycle and lower the specification limit of the dynamic current test; and 3) an increase to the time to measure the micro awake current.
P860019/S264

3/31/11

135-Day

Apex Monorail and Apex Over-the-Wire PTCA Dilation Catheter/Maverick 2 Monorail PTCA Catheter/Maverick Over-the-Wire PTCA Catheter/Maverick Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P880006/S067

3/4/11

180-Day

Merlin Patient Care System St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System.
P880086/S189

3/4/11

180-Day

Merlin Patient Care System St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System.
P890003/S177

3/25/11

180-Day

Carelink Monitor and CardioSight® Reader Medtronic, Inc.

Mounds View, MN 55112

Approval for Protecta™ XT CRT-D D314TRG and Protecta™ CRT-D D334TRG Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™ XT DR D314DRG, Protecta™ XT VR D314VRG, Protecta™ DR D334DRG, and Protecta™ VR D334VRG Implantable Cardioverter Defibrillators, Model SW009 Application Software v1.0, Carelink Monitor Model 2490C upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.
P890003/S178

3/22/11

Real-Time

Software Version SW003 (version 7.1); Relia Application Software Version SW010 (version 7.1); and Carelink DDMA Version K3 DDMA1 2v4 Medtronic, Inc.

Mounds, View, MN

55112

Approval for nEw Application Software Version SW003 (version 7.1); Relia Application Software Version SW010 (version 7.1); and Carelink DDMA Version K3 DDMA1 2v4.
P890003/S189

3/22/11

180-Day

Consulta CRT-P and Syncra CRT-P Implantable Pulse Generators with Cardiac Resynchronization, Medtronic, Inc.

Mounds View, MN

55112

Approval for the Consulta CRT-P C4TR01 and Syncra CRT-P C2TR01 Implantable Pulse Generators with Cardiac Resynchronization, Software Model 9995 (version 7.3), CareLink Monitor Model 2490G and Model 2491 DDMA.
P890003/S192

3/22/11

180-Day

Preva, Prevade and Prodigy IPGs Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P890003/S195

3/17/11

Real-Time

CareLink Remote Home Monitor Medtronic, Inc.

Mounds View, MN

55112

Approval to reduce the 21-day scheduling of device interrogation requirement within the device firmware, as well as labeling modifications to disclose the effects of this programmability on the longevity of the pulse generators.
P890003/S210

3/17/11

Real-Time

CareLink Home Monitor, Device and Data Management Application and CardioSight Reader Medtronic, Inc.

Mounds View, MN

55112

Approval for modifications to the CareLink Home Monitor Model 2490G, Device and Data Management Application Model 2491, and CardioSight Reader Model 2020A.
P890055/S028

3/15/11

180-Day

MedStream Programmable Infusion System Codman & Shurtleff, Inc.

Raynham, MA

02767

Approval of the post-approval study protocol.
P890055/S029

3/15/11

180-Day

MedStream Programmable Infusion System Codman & Shurtleff, Inc.

Raynham, MA

02767

Approval of the post-approval study protocol.
P890055/S030

3/15/11

180-Day

MedStream Programmable Infusion System Codman & Shurtleff, Inc.

Raynham, MA

02767

Approval of the post-approval study protocol.
P900056/S103

3/31/11

135-Day

Rotablator Rotational Angioplasty System Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P910007/S019

3/22/11

180-Day

ARCHITECT Total PSA Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo Ireland.
P910023/S236

3/4/11

180-Day

Merlin Patient Care System St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System.
P910077/S110

3/3/11

Real-Time

Latitude Patient Management System Guidant Corporation ( Boston Scientific Corporation)

St. Paul, MN

55112

Approval for modification to the

Latitude Patient Management System Regulated Application Software v7.0.02 on Latitude System Server (Model 6488) and Related Communicator Software Changes (Model 6476).

P920047/S044

3/31/11

135-Day

Blazer II XP Cardiac Ablation Catheter/Cable/ Blazer II High Torque Distal (HTD) Ablation Catheter/Cable/ Blazer Prime Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P930016/S034

3/4/11

180-Day

STAR S4 IR Excimer Laser System with Variable Spot Scanning and WaveScan WaveFront System AMO Manufacturing USA, LLC

Milpitas, CA

95035

Approval for WaveScan Wave- Front Software Version 3.68.
P950029/S056

3/22/11

Real-Time

Reply/Esprit SR/DR Pacers Ela Medical ,Inc. (Sorin Group)

Plymouth, MN

55441

Approval for a new Setscrew and Torque-limiting Screwdriver Accessory.
P950037/S091

3/25/11

180-Day

Envia, Entovis, Estella, Ecuro and Effecta Family of Pulse Generators Biotronik, Inc.

Lake Oswego, OR 97035

Approval for updated integrated circuits for use in the currently marketed Evia/ Entovis/Estella/ Ecuro/Effecta family of pulse generators.
P960011/S018

3/8/11

180-Day

BVI 1% OVD Sodium Hyaluronate Ferring Pharmaceuticals, Inc.

Parsippany, NJ

07054

Approval for 1) the inclusion of directions for proper finger flange orientation in the Instructions for Use, and approval to change the trade name of the device from BD 1% OVD Sodium Hyaluronate to BVI 1% OVD Sodium Hyaluronate.
P970012/S068

3/22/11

180-Day

Kappa IPGs Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P970013/S034

3/4/11

180-Day

Merlin Patient Care System St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System.
P980003/S024

3/31/11

135-Day

Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P980007/S011

3/31/11

180-Day

Abbott Architect Free PSA Abbott Laboratories

Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P980016/S211

3/25/11

180-Day

Protecta™ XT DR, Protecta™ XT VR, Protecta™ DR, and Protecta™ VR, Implantable Cardioverter Defibrillators;

Model SW009 Application Software vi.0 Systems

 

Medtronic, Inc.

Mounds View, MN 55112

Approval for Protecta™ XT CRT-D D314TRG and Protecta™ CRT-D D334TRG Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™ XT DR D314DRG, Protecta™ XT VR D314VRG, Protecta™ DR D334DRG, and Protecta™ VR D334VRG Implantable Cardioverter Defibrillators, Model SW009 Application Software v1.0, Carelink Monitor Model 2490C upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.
P980016/S240

3/22/11

180-Day

Marquis DR/VR; Maximo DR/VR; Intrinsic 30 /Intrinsic; EnTrust; Maximo II; Virtuoso DR; Virtuoso II; Secura Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P980016/S268

3/22/11

Real-Time

Maximo II, Secura, and Virtuoso II Medtronic, Inc.

Mounds View, MN

55112

Approval for the design changes to the Multilayer Ceramic Capacitors (XC308, XC251, XC259, and XC263) for Concerto II Model D274TRK; Consulta Model D224TRK; and Maximo II Model

D284TRK; Maximo II Models D284DRG, D2S4VRC; Secura Models D224DRG, D224VRC; and

Virtuoso Models D274DRG. D274VRG; EnRhythm Model P1501DR; Vitatron DA+ C- Series Models C20A1, C20A3, C60A1, C60A3; and Vitatron DA+ T-Series Models T2OA1, T6OA1;

P980035/S147

3/22/11

Real-Time

nEw Application Software Version SW003 (version 7.1); Relia Application Software Version SW010 (version 7.1); and Carelink DDMA Version K3 DDMA1 2v4 Medtronic, Inc.

Mounds, View, MN

55112

Approval for nEw Application Software Version SW003 (version 7.1); Relia Application Software Version SW010 (version 7.1); and Carelink DDMA Version K3 DDMA1 2v4.
P980035/S168

3/22/11

180-Day

Adapta; Relia; Sensia; Versa; Kappa; EnPulse; Sigma Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P980035/S197

3/22/11

Real-Time

EnRhythm Medtronic, Inc.

Mounds View, MN

55112

Approval for the design changes to the Multilayer Ceramic Capacitors (XC308, XC251, XC259, and XC263) for Concerto II Model D274TRK; Consulta Model D224TRK; and Maximo II Model

D284TRK; Maximo II Models D284DRG, D2S4VRC; Secura Models D224DRG, D224VRC; and

Virtuoso Models D274DRG. D274VRG; EnRhythm Model P1501DR; Vitatron DA+ C- Series Models C20A1, C20A3, C60A1, C60A3; and Vitatron DA+ T-Series Models T2OA1, T6OA1;

P980037/S034

3/17/11

Real-Time

AngioJet® Rheolytic™ Thrombectomy System Medrad Interventional/ Possis

Minneapolis, MN

55433

Approval for changes to the AngioJet Ultra Console software.
P990001/S068

3/22/11

180-Day

Vitatron DA+ C Series and T Series IPGs; Jade II, Topaz II, Vita IPGs Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P990001/S080

3/22/11

Real-Time

Vitatron DA+ C-Series; and Vitatron DA+T-Series Medtronic, Inc.

Mounds View, MN

55112

Approval for the design changes to the Multilayer Ceramic Capacitors (XC308, XC251, XC259, and XC263) for Concerto II Model D274TRK; Consulta Model D224TRK; and Maximo II Model

D284TRK; Maximo II Models D284DRG, D2S4VRC; Secura Models D224DRG, D224VRC; and

Virtuoso Models D274DRG. D274VRG; EnRhythm Model P1501DR; Vitatron DA+ C- Series Models C20A1, C20A3, C60A1, C60A3; and Vitatron DA+ T-Series Models T2OA1, T6OA1;

P000021/S018

3/11/11

180-Day

Dimension® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for software changes (Version 3.1.1. to 3.3.) and associated hardware changes to the Dimension Vista® System.
P010013/S031

3/9/11

135-Day

NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.

Marlborough, MA

01752

Approval for an annealing process to the molded front grip component.
P010015/S084

3/22/11

180-Day

Consulta CRT-P and Syncra CRT-P Implantable Pulse Generators with Cardiac Resynchronization, Software Model 9995 (version 7.3), CareLink Monitors Medtronic, Inc.

Mounds View, MN 55112

Approval for the Consulta CRT-P C4TR01 and Syncra CRT-P C2TR01 Implantable Pulse Generators with Cardiac Resynchronization, Software Model 9995 (version 7.3), CareLink Monitor Models 2490G and Model 2491 DDMA.
P010015/S086

3/22/11

180-Day

InSync/InSync III CRT-Ps Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P010031/S171

3/25/11

180-Day

Protecta™ XT CRT-D and Protecta™ CRT-D Implantable Cardioverter Defibrillators with Cardiac Resynchronization; Model SW009 Application Software vi.0 Systems Medtronic, Inc.

Mounds View, MN 55112

Approval for Protecta™ XT CRT-D D314TRG and Protecta™ CRT-D D334TRG Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™ XT DR D314DRG, Protecta™ XT VR D314VRG, Protecta™ DR D334DRG, and Protecta™ VR D334VRG Implantable Cardioverter Defibrillators, Model SW009 Application Software v1.0, Carelink Monitor Model 2490C upgrade, CardioSight Reader Model 2020A upgrade, and Model 2491 DDMA upgrade.
P010031/S198

3/22/11

180-Day

InSync II Marquis; InSync III Marquis; InSync Sentry; InSync Maximo; Concerto; Concerto II; Consulta; Maximo II Medtronic, Inc.

Mounds, View, MN

55112

Approval for the change of the materials, power supply, and incoming inspection

process for the following AVX capacitors to be used in the above referenced IPGs. Those capacitors are:

XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,

XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,

XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,

XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,

XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,

XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,

XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,

XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, and XT114.

P010031/S222

3/22/11

Real-Time

Concerto II, Consulta, and Maximo II Medtronic, Inc.

Mounds View, MN

55112

Approval for the design changes to the Multilayer Ceramic Capacitors (XC308, XC251, XC259, and XC263) for Concerto II Model D274TRK; Consulta Model D224TRK; and Maximo II Model

D284TRK; Maximo II Models D284DRG, D2S4VRC; Secura Models D224DRG, D224VRC; and

Virtuoso Models D274DRG. D274VRG; EnRhythm Model P1501DR; Vitatron DA+ C- Series Models C20A1, C20A3, C60A1, C60A3; and Vitatron DA+ T-Series Models T2OA1, T6OA1;

P020009/S066

3/31/11

135-Day

Express 2 Monorail and Over-the-Wire Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P020025/S025

3/31/11

135-Day

Blazer II XP Cardiac Ablation Catheter and Cable/Blazer Prime XP Cardiac Ablation Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P020026/S081

3/3/11

135-Day

CYPHER® Sirolimus-Eluting Coronary Stent, Coronary Stent on RAPTOR™ Over-the-Wire Delivery System/

RAPTORRAIL® Rapid Exchange Delivery System (Cypher Stent®)

Cordis Corporation Miami Lakes, FL

33014

Approval for automation of your stent coating process.
P020027/S013

3/11/11

180-Day

Dimension® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc. Newark, DE

19714

Approval for software changes (Version 3.1.1 to 3.3) and associated hardware changes to the Dimension Vista® System.
P030019/S017

3/18/11

135-Day

Orthovisc® Anika Therapeutics, Inc.

Bedford, MA

01730

Approval for the sample preparation of raw material hyaluronate acid to be changed from its current formulation to a more diluted test sample.
P030025/S091

3/31/11

135-Day

Taxus Express 2 Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P030031/S023

3/3/11

135-Day

NaviStar® Thermocool® Diagnostic/Ablation Deflectable Tip Catheter Biosense Webster, Inc.

Diamond Bar, CA 91765

Approval for addition of a label during a manufacturing process step.
P030034/S005

3/11/11

Real-Time

Cervical-Stim Orthofix, Inc.

Lewisville, TX

75056

Approval for design modifications to the garment covering, the treatment coils, liquid crystal display, control unit housing profile, orientation of the controls, software/ firmware, power supply cord, and labeling. The device, as modified, will be marketed under the trade name Cervical-Stim and is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fushion.
P030035/S070

3/4/11

180-Day

Merlin Patient Care System St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System.
P030036/S004

3/30/11

180-Day

SelectSecure Lead Medtronic, Inc.

Mounds View, MN 55112

Approval for improvements to the chemistry, manufacturing, and controls (CMC) and elution methods and specifications for the drug coating on SelectSecure Model 3830 leads.
P030052/S004

3/22/11

Special

UroVysion Bladder Cancer Kit Abbott Molecular, Inc.

Des Plaines, IL

60018

Approval to provide the definition for the pepsin activity of the Vysis protease reagent in the UroVysion package insert.
P030053/S011

3/17/11

180-Day

MemoryGel™ Silicone-filled Breast implant Mentor Corporation

Santa Barbara, CA

93111

Approval of the post-approval study protocol.
P030054/S153

3/4/11

180-Day

Merlin Patient Care System St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System.
P040016/S063

3/31/11

135-Day

Veriflex (Liberté) Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P040033/S020

3/16/11

Special

Birmingham Hip Resurfacing (BHR) System Smith & Nephew Orthopaedics

Cordova, TN

38016

Approval for revisions to the surgical technique manual.
P040036/S016

3/3/11

135-Day

NaviStar® Thermocool® Diagnostic/Ablation Deflectable Tip Catheter Biosense Webster, Inc.

Diamond Bar, CA 91765

Approval for addition of a label during a manufacturing process step.
P050007/S028

3/24/11

Special

Starclose SE Vascular Closure

System

Abbott Vascular Devices

Redwood City, CA 94063

Approval to add adjunctive compression language to the labeling and instructions for use.
P050010/S010

3/3/11

135-Day

ProDisc™-L Total Disc Replacement Synthes Spine

West Chester, PA 19380

Approval for a change from a manual deburring process to an automated brush deburring process.
P050018/S012

3/30/11

180-Day

AngioSculpt® PTCA Scoring Balloon Catheter AngioScore

Fremont, CA

94538

Approval for a manufacturing site located at Sterigenics in Salt Lake City, Utah.
P050039/S005

3/31/11

Special

Exactech® Novation™ Ceramic AHS® Articulation Hip System Exactech, Inc.

Gainesville, FL 32653

Approval for labeling changes which add strengthening language to the femoral stem surgical technique manuals.
P050042/S010

3/22/11

180-Day

ARCHITECT Anti-HCV Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P050043/S004

3/17/11

Real-Time

Femoral Introducer Sheath and Hemostatic Device (FISH), FISH-SP Device Morris Innovative Bloomington, IN

47403

 

Approval for: 1) replacing the sewn two-piece small intestine submocosa (SIS) assembly with a single SIS piece; 2) decreasing the SIS cuff length and ribbon width; 3) modifying the SIS patch to release wire connection; and 4) changing the sheath material from a high density polyethylene (HDPE) to fluorinated ethylene propylene (FEP).
P050047/S015

3/25/11

Special

Juvéderm Hyaluronate Gel Implants Allergan Medical Goleta, CA

93117

Approval for some labeling updates to improve the safe use of the device.
P050051/S009

3/22/11

180-Day

ARCHITECT AUSAB Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P060001/S011

3/8/11

180-Day

Protégé GPS and Protégé RX Carotid Stent Systems eV3, Inc.

Plymouth, MN

55441

Approval of the post-approval study protocol.
P060004/S001

3/28/11

Panel-Track

MEL 80™ Excimer Laser System Carl Zeiss Meditec, Inc.

Dublin, CA

94568

Approval for the MEL 80™ Excimer Laser System. This device uses an optical zone of 6.0 to 6.5 mm in diameter and a transition zone of 2.0 to 4.0 mm for a total ablation diameter of 10.0 mm, and is indicated for primary Laser Assisted in situ Keratomileusis (LASIK) treatments for: 1) the reduction or elimination of naturally-occurring hyperopia of less than or equal to

+5.0 D with or without refractive astigmatism of > +0.5 and ≤ +3.0D, with a maximum MRSE of +5.0D; 2) in patients who are 21 years of age or older; and 3) with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of ≤ 0.5D.

P060006/S017

3/31/11

135-Day

Express SD Monorail Premounted Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P060007/S007

3/22/11

180-Day

ARCHITECT HBsAg/ Confirmatory Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P060008/S057

3/1/11

180-Day

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for updating the Patient Guide into two separate documents (Angioplasty and Stent Education Guide and Patient Information Guide).
P060008/S060

3/31/11

135-Day

Taxus Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Approval for a change to the sterilization equipment.
P060008/S068

3/11/11

180-Day

TAXUS Liberté® Boston Scientific Corporation

Maple Grove, MN

55311

Approval of the post-approval study protocol.
P060018/S002

3/24/11

135-Day

PRESTIGE® Cervical Disc Medtronic Sofamor Danek

Memphis, TN

38132

Approval for a change of location of the Orchid Anzon (formerly Anzon Company, Inc.) facility.
P060035/S006

3/22/11

180-Day

ARCHITECT CORE-M Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P070009/S012

3/31/11

135-Day

REALIZE Adjustable Gastric Band with Injection Port and Applier Ethicon Endo-Surgery, Inc.

Cincinnati, Oh

45242

Approval for the use of an alternate supplier for the injection molding of the septum and connector sleeve components of the injection port.
P070009/S013

3/31/11

Real-Time

REALIZE® Adjustable Gastric Band with Injection Ports & Applier and REALIZE® Adjustable Gastric Band-C with Injection Ports & Applier and Injection Port Ethicon Endo-Surgery, Inc.

Cincinnati, OH

45242

Approval for a device change to modify the silicone material used for the Injection Port septum and Injection Port connector sleeve components, along with a minor associated labeling modification.
P070014/S020

3/17/11

180-Day

LifeStent Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Approval of the post-approval study protocol.
P080006/S004

3/31/11

180-Day

Attain Ability Straight Left Ventricular Lead Medtronic, Inc.

Mounds View, MN 55112

Approval for the Attain Ability Straight Model 4396 Left Ventricular Lead. The Model 4396 lead is a 4 French, transvenous, steroid eluting, dual electrode, polyurethane insulated, single coil, straight tip, tine fixation lead intended for use in left heart coronary veins.
P080011/S004

3/23/11

180-Day

Biofinity Contact Lenses CooperVision, Inc. Pleasanton, CA

94588

Approval for an alternate labeling and packing site located at Cooper- Vision Inc., West Henrietta, New York.
P080014/S005

3/29/11

Real-Time

CERVISTA HPV HR Hologic, Inc.

Marlborough, MA 01752

Approval for the increase of the volume of the HPV control in Cervista HPV HR test and labeling changes to the package insert.
P080015/S002

3/29/11

Real-Time

 

CERVISTA HPV 16/18 Hologic, Inc. Marlborough, MA 01752 Approval for the increase of the volume of the HPV control in Cervista HPB 16/18 test and labeling changes to the package insert.
P080023/S006

3/22/11

180-Day

ARCHITECT CORE Abbott Laboratories Abbott Park, IL 60064 Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P080029/S001

3/11/11

180-Day

Quick-Close® Vascular Suturing System Interventional Therapies, LLC

North Attleboro, MA

02760

Approval for ergonomic changes to the Quick-Close® Vascular Suturing System.
P100010/S005

3/24/11

Real-Time

Arctic Front® Cardiac CryoAblation Catheter Medtronic CryoCath LP

Quebec, Canada

H9R 5Z8

Approval for a labeling change to extend the shelf-life of the device.

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

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N12159/S027

3/4/11

Surgicel Original, Surgicel Fibrillar and Surgicel

NU-KNIT Absorbable Hemostats

Ethicon Incorporated

Somerville, NJ

08876

Alternate cycle for the dehumidification oven.
N16895/S093

3/4/11

Bausch & Lomb SofLens (polymacon) Visibility Tinted Contact Lenses Bausch & Lomb, Incorporated

3/4/11

Change to transfer raw material supplier processing from Sarasota, Florida to Germany.
P830061/S060

3/30/11

CapSure, Vitatron, Crystaline, Vitatron Excellence PS+ Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P840001/S179

3/9/11

Restore Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Implementation of an additional automated plating line at the plating supplier.
P840001/S180

3/9/11

Itrel®, Synergy® and Synergy Versitrel® IPGs, RestorePrime®, PrimeAdvanced®, Restore®, RestoreUltra® and RestoreAdvanced® INS Medtronic, Inc.

Minneapolis, MN

55432

Modification to epoxy dispense equipment parameters.
P840001/S181

3/17/11

Itrel 3 INS, Synergy Family INS, Pocket Adaptors Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of a new manufacturing mold and component supplier.
P850079/S049

3/16/11

Frequency XCEL Toric (Methafilcon a) Soft Contact Lens CooperVision, Inc.

Pleasanton, CA

94588

Change in location of the wet processing area and the use of an alternate biological indicator for sterilization release.
P850089/S073

3/30/11

Capsure, Z Novus, Vitatron, Excellence SS+, Impulse II Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P860004/S146

3/9/11

SynchroMed II Implantable Drug Pump Medtronic, Inc.

Minneapolis, MN

55432

Implementation of an additional automated plating line at the plating supplier.
P860004/S148

3/22/11

SynchroMed II Infusion Pump Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of two new laser welding workstations and two new laser power supplies to the manufacturing process of the Implantable SynchroMed II Infusion Pump, Model 8637.
P860057/S076

3/3/11

Carpentier-Edwards PERIMOUNT® Pericardial Bioprostheses Heart Valve Edwards Lifesciences, LLC

Irvine, CA

92614

Addition of a new vessel for the Gluteraldehyde mixing process.
P870072/S047

3/10/11

Thoratec® Ventricular Assist Device (VAD) Surgical Implant Accessory Kit Thoratec Corporation

Pleasanton, CA

94588

Moving a manufacturing process in-house from a contract manufacturer.
P880047/S014

3/2/11

Gynecare Interceed Absorbable Adhesion Barrier Ethicon, Inc.

Somerville, NJ

08876

Change in the density limit for irradiation shippers.
P890003/S215

3/17/11

Prodigy IPG Medtronic, Inc. Mounds View, MN 55112 Update to the sterile packaging operation process.
P890003/S216

3/30/11

CapSure, CapSure Model, Service Kit Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P890064/S025

3/29/11

digene® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test QIAGEN Gaithersburg, Inc.

Gaithersburg, MD

20878

Changes for digene® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test located in Gaithersburg, MD.
P900061/S099

3/30/11

Accessory – Upsizing Sleeve, Lead End Pin Cap Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P910007/S027

3/7/11

ARCHITECT Total PSA Abbott Laboratories

Abbott Park, IL

60064

Change in the vendor of antifoam raw material for use in the ARCHITECT Total PSA.
P920015/S073

3/30/11

Sprint Quattro, Subcutaneous Lead, Transvene SVC Lead Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P930014/S047

3/9/11

AcrySof ReSTOR Intraocular Lenses and AcrySof IQ Toric Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Implementation of a software modification to enhance and improve intraocular lens production.
P930039/S048

3/30/11

CapSure, SureFix, Vitatron Crystalline ActFix, Vitatron Pirouet S+ Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P940015/S020

3/18/11

Synvisc® and Synvisc-One® Genzyme Corporation

Cambridge, MA

02142

Filling of an investigational drug on the INOVA filler machine, which is also used for filling the Synvisc® and Synvisc-One® products.
P950005/S032

3/3/11

Webster Electrophysiology Catheter, CELSIUS Ablation Catheter Biosense Webster, Inc.

Diamond Bar, CA 91765

Addition of a supplier for catheter tip electrodes.
P950008/S008

3/10/11

SILIKON 1000 Alcon Research Ltd.

Fort Worth, TX

76134

Establish ISO classification for two controlled environment areas.
P950024/S028

3/30/11

CapSure Epicardial Pacing Medtronic, Inc.

Mounds View, MN 55112

Update to the sterile packaging operation process.
P950029/S057

3/3/11

REPLY SR/DR and ESPIRIT SR/DR Implantable Pacemakers ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Removal of a hybrid baking step, and the addition of a hybrid cleaning step.
P960004/S048

3/24/11

THINLINE® II STEROX, FINELINE® II STEROX and FINELINE® II STEROX EZ Boston Scientific Corporation

St. Paul, MN

55112

Change from a scrub method of cleaning a lead body to a wipe method.
P960009/S109

3/9/11

Activa® Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Implementation of an additional automated plating line at the plating supplier.
P960009/S110

3/9/11

Soletra®, Kinetra® Activa® PC and Activa® RC Medtronic, Inc.

Minneapolis, MN

55432

Modification to epoxy dispense equipment parameters.
P960009/S111

3/17/11

Activa SC INS, Soletra INS, Kinetrea INS, Pocket Adaptors Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of a new manufacturing mold and component supplier.
P960022/S008

3/28/11

SofLens66 and SofLens Toric (alphafilcon A) Soft Contact Lenses Bausch & Lomb, Inc.

Rochester, NY

14609

Change with the supplier of the raw material processing for the SofLens66 and SofLens Toric (alphafilcon A) Soft Contact Lenses.
P960042/S028

3/7/11

SLS II Spectranetics Laser Sheaths Spectranetics Corporation

Colorado Springs, CO

80921

Change the process for dispensing fluid adhesive from a manual method to a semi-automated method.
P970003/S122

3/2/11

VNS Therapy® System Cyberonics, Inc.

Houston, TX

77058

Addition of a cleaning step for the Printed Circuit Board.
P970003/S123

3/25/11

VNS Therapy® System Cyberonics, Inc.

Houston, TX

77058

Change to the pulse generator manufacturing process.
P970004/S105

3/9/11

InterStim® Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Implementation of an additional automated plating line at the plating supplier.
P970004/S106

3/9/11

InterStim® and InterStim® II INS Medtronic, Inc.

Minneapolis, MN

55432

Modification to epoxy dispense equipment parameters.
P970004/S107

3/17/11

InterStim INS Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of a new manufacturing mold and component supplier.
P970008/S055

3/2/11

Urologix Targis System for the Treatment of BPH Urologix, Inc.

Minneapolis, MN

55447

Removal of a tube trimming step and move the Control Unit keyboard assembly process in house.
P970012/S083

3/18/11

Kappa 400 Medtronic, Inc.

Mounds View, MN

55112

New mold and an additional supplier for seal components.
P970013/S039

3/30/11

Microny Family of Pacemakers St. Jude Medical – CRMD

Sylmar, CA

91342

Alternate supplier for pace wires.
P970020/S061

3/18/11

Multi-Link Zeta RX Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change in resin verification at receiving inspection.
P970037/S004

3/4/11

AutoDELFIA®/ DELFIA Xpress hAFP PerkinElmer, Inc. Indianapolis, IN

46236

Change in the supplier of a raw material.
P970051/S067

3/2/11

Nucleus 24 Cochlear Implant System Cochlear Americas Centennial, CO 80111 Changes to the manufacturing process for the use of new silicone injection molding equipment.
P980007/S018

3/7/11

ARCHITECT Free PSA Abbott Laboratories

Abbott Park, IL

60064

Change in the vendor of antifoam raw material for use in the ARCHITECT Free PSA assays.
P980016/S278

3/2/11

Secura DR/VR, Maximo II DR/VR, and Virtuoso II DR/VR ICDs Medtronic, Inc. Mounds View, MN 55112 Change in supplier component testing.
P980016/S281

3/17/11

Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR/V ICDs Medtronic, Inc.

Mounds View, MN

55112

Implementation of a new device manufacturing assembly line.
P980016/S282

3/24/11

Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR ICDs Medtronic, Inc. Mounds View, MN 55112 Addition of a dry plasma oxygen clean process step.
P980016/S283

3/18/11

Marquis, Maximo Medtronic, Inc.

Mounds View, MN

55112

New mold and an additional supplier for seal components.
P980016/S284

3/17/11

Secura DR/VR ICD, Virtuoso II DR/VR, Maximo II DR/VR, Entrust ICD, Virtuoso ICD Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P980016/S285

3/31/11

Maximo II, Secura, Virtuoso II ICDs Medtronic, Inc.

Mounds View, MN

55112

Addition of a new equipment controller for the print label files.
P980022/S095

3/30/11

Continuous Glucose Monitoring System, SOF-Sensor, Glucose Sensors Medtronic MiniMed Northridge, CA

91325

Change to use a semi-automated tape application during sensor base assembly.
P980035/S203

3/3/11

Adapta, Relia, Sensia, Versa IPGs Medtronic, Inc.

Mounds View, MN

55112

Implementation of a new release of traceability software.
P980035/S204

3/24/11

Adapta, Versa, Sensia, Relia IPGs Medtronic, Inc. Mounds View, MN 55112 Addition of a dry plasma oxygen clean process step.
P980035/S205

3/18/11

350 Series, Adapta, EnPulse, Kappa 600/650/700/800/ 900, Sigma Medtronic, Inc.

Mounds View, MN

55112

New mold and an additional supplier for seal components.
P980035/S206

3/17/11

Adapta/Versa/ Sensia IPG Family, Relia IPG and EnRhythm IPG Medtronic, Inc. Mounds View, MN 55112 Update to the sterile packaging operation process.
P980035/S207

3/31/11

Adapta, Relia, Sensia, Versa IPGs Medtronic, Inc.

Mounds View, MN

55112

Addition of a new equipment controller for the print label files.
P980049/S063

3/31/11

Isoline 2CT and Isoline 2CR Leads ELA Medical, Inc. Plymouth, MN

55441

Update to the current leads label printing software.
P980050/S058

3/30/11

Transvene CS/SVC Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P990001/S085

3/31/11

Vitatron DA+C, Vitatron DA+T Series IPGs Medtronic, Inc.

Mounds View, MN

55112

Addition of a new equipment controller for the print label files.
P990004/S021

3/2/11

Surgifoam Absorbable Gelatin Sponge, U.S.P. Ethicon, Inc.

Somerville, NJ

08876

Change in packaging line equipment.
P990009/S031

3/16/11

Floseal Hemostatic Matrix Baxter Healthcare Corporation

McGaw Park, IL

60085

Changes in the manufacturing methods or processes.
P990025/S027

3/3/11

NAVISTAR RMT Catheter Biosense Webster, Inc.

Diamond Bar, CA 91765

Addition of a supplier for catheter tip electrodes.
P000010/S020

3/22/11

AMPLICOR HCV Test, v.2.0/COBAS AMPLICOR HCV Test v2.0 Roche Molecular Systems, Inc.

Pleasanton, CA 94588

Discontinuation of Final Bulk Testing requirements for bulk Quantitation Standard (QS) and Internal Control (IC) reagents for 17 QS/IC products used with the associated assays.
P000012/S029

3/22/11

COBAS AmpliPrep /COBAS AMPLICOR HCV Test v2.0 Roche Molecular Systems, Inc.

Pleasanton, CA 94588

Discontinuation of Final Bulk Testing requirements for bulk Quantitation Standard (QS) and Internal Control (IC) reagents for 17 QS/IC products used with the associated assays.
P000014/S023

3/10/11

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator Ortho-Clinical Diagnostics

Rochester, NY

14626

Change to manufacture and store the antifoam solution used in VITROS Anti-HBs Conjugate Reagent.
P000020/S014

3/17/11

Stinger, Stinger S, Stinger M, Stinger SM, Scorpion 2 and Scorpion 2M Ablation Catheters and Templink/ Templink M Extension Cables C.R. Bard, Inc.

Lowell, MA

01851

Addition of a new supplier for connector assemblies and plug cable connectors.
P010014/S030

3/24/11

Oxford Partial Knee System Biomet, Inc.

Warsaw, IN

46581

Change to the heat sealing of blister packs procedure by adding a new benchtop sealer.
P010015/S109

3/30/11

Attain Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P010019/S020

3/16/11

CIBA VISION (lotrafilcon B) Soft Contact Lenses CIBA VISION Corporation

Duluth, GA

30097

Change the endotoxin testing site to the CIBA VISION Johor Microbiology Laboratory in Johor, Malaysia.
P010023/S008

3/2/11

Maxum System Ototronix, LLC

St. Paul, MN

55110

Change to the IPC shell fabrication process.
P010030/S026

3/28/11

LifeVest Wearable Cardioverter ZOLL Lifecor Corporation

Pittsburgh, PA

15238

Addition of a new thermoforming machine.
P010031/S234

3/2/11

Concerto CRT-D, Maximo II CRT-D, and Concerto II ICD Medtronic, Inc.

Mounds View, MN 55112

Change in supplier component testing.
P010031/S236

3/17/11

Concerto, Concerto II ICD, Consulta CRT-D, Maximo II CRT-D Medtronic, Inc.

Mounds View, MN

55112

Implementation of a new device manufacturing assembly line.
P010031/S237

3/24/11

Concerto II ICD, Consulta, Maximo II CRT-Ds Medtronic, Inc. Mounds View, MN 55112 Addition of a dry plasma oxygen clean process step.
P010031/S238

3/17/11

InSync Sentry CRT-D, Concerto ICD, Consulta CRT-D, Concerto II CRT-D, Maximo II CRT-D Medtronic, Inc. Mounds View, MN 55112 Update to the sterile packaging operation process.
P010031/S239

3/31/11

Concerto II, Consulta, Maximo II CRT-Ds Medtronic, Inc.

Mounds View, MN

55112

Addition of a new equipment controller for the print label files.
P010068/S022

3/3/11

CELSIUS DS Ablation Catheter Biosense Webster, Inc.

Diamond Bar, CA 91765

Addition of a supplier for catheter tip electrodes.
P020004/S059

3/16/11

GORE EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86003

Removal of a cooling chamber and an update to the touch screen software.
P020004/S060

3/18/11

GORE EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86003

Automation of a trimming process.
P020030/S008

3/31/11

Stelix BR, Stelix II BRF, and Stelid II BTF/BJF Leads ELA Medical, Inc. Plymouth, MN

55441

Update to the current leads label printing software.
P020047/S030

3/18/11

Multi-Link Vision and Multi-Link Mini Vision OTW and RX Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change in resin verification at receiving inspection.
P020047/S031

3/18/11

Multi-Link Vision®, Multi-Link Mini Vision®, Multi-Link 8™, Multi-Link 8™ LL and Multi-Link 8™ SV Coronary Stent Systems Abbott Vascular Temecula, CA 92591 Change in quality control testing for balloon rupture.
P030002/S023

3/29/11

Crystalens® Accomodating Intraocular Lens Bausch & Lomb, Inc.

Aliso Viejo, CA

92656

Relocation of the final inspection and pre-pack operation at the manufacturing facility located in Rancho Cucamonga, California.
P030017/S116

3/28/11

Precision® Spinal Cord Stimulator System Boston Scientific Corporation

Valencia, CA 91355

Addition of an alternate assembly method for the leads and extensions for the Precision® Spinal Cord Stimulator (SCS) System.
P030017/S117

3/30/11

Precision® Spinal Cord Stimulator (SCS) System Boston Scientific Corporation

Valencia, CA

91355

Addition of pouch sealing equipment for the in-house processing of products packaged in Tyvek pouches.
P030029/S012

3/14/11

ADVIA Centaur Anti-HBs Assay Siemens Healthcare Diagnostics

East Walpole, MA

02032

Change of raw material used in the production of the Lite Reagent buffer.
P030036/S026

3/30/11

SelectSecure Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P040012/S037

3/30/11

Acculink Carotid Stent System Abbott Vascular, Inc.

Santa Clara, CA

95054

Changes to the in- process inspection and specification for the Inner Member (IM) to hypotube bond of the device.
P040012/S038

3/30/11

Acculink Carotid Stent System Abbott Vascular, Inc.

Santa Clara, CA

95054

Addition of an alternate heat sealer.
P040016/S070

3/18/11

VeriFLEX (Liberté) Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Change in bacterial endotoxin test methodology.
P040020/S030

3/9/11

AcrySof ReSTOR and AcrySof IQ Toric Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Implementation of a software modification to enhance and improve intraocular lens production.
P040038/S021

3/30/11

Xact® Carotid Stent System Abbott Vascular, Inc.

Santa Clara, CA

95054

Addition of an alternate heat sealer.
P040043/S038

3/16/11

GORE® TAG® Thoracic Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86003

Removal of a cooling chamber and an update to the touch screen software.
P040044/S036

3/10/11

Mynx® Vascular Closure Device Access Closure, Inc. Mountain View, CA

94043

Addition of a supplier for subassemblies of the Mynx product family.
P050012/S036

3/2/11

DexCom Seven and Seven Plus Continuous Glucose Monitoring System DexCom Inc.

San Diego, CA

92121

Alternate Vendor and method of manufacture of the disposable seal component of the applicator assembly of the Seven and Seven Plus systems. The proposed change applies only to the disposable seal supplier and the method of manufacture; neither the materials nor the final design of the disposable seal are altered. Sensor performance and release specification will also remain unchanged.
P050020/S033

3/10/11

Freestyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care, Inc.

Alameda, CA

04502

Addition of an alternate supplier of the injection molded components of the Freestyle Navigator Continuous Glucose Monitoring System.
P050028/S016

3/22/11

COBAS TaqMan HBV Test for use with The High Pure System Roche Molecular Systems, Inc.

Pleasanton, CA 94588

Discontinuation of Final Bulk Testing requirements for bulk Quantitation Standard (QS) and Internal Control (IC) reagents for 17 QS/IC products used with the associated assays.
P050034/S005

3/31/11

Implantable Miniature Telescope (IMT) VisionCare Ophthalmic Technologies, Inc. Saratoga, CA

95070

Change to the biological indicator used in the sterilization process and to add an option for a second full cycle sterilization (double sterilization) to the manufacturing process if required.
P050051/S010

3/23/11

ARCHITECT AUSAB Abbott Laboratories Abbott Park, IL

60064

Changes in two quality control test methods used for in-process testing of bulk components.
P060007/S008

3/30/11

ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Assays Abbott Laboratories Abbott Park, IL 60064 Specification change for the negative human plasma for the HBsAg assays.
P060007/S009

3/30/11

ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Assays Abbott Laboratories Abbott Park, IL 60064 Test method conversions for calf bovine serum for the two HBsAg assays.
P060007/S010

3/30/11

ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Assays Abbott Laboratories Abbott Park, IL 60064 Plasma test method conversions for ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Assays.
P060007/S011

3/30/11

ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Assays Abbott Laboratories Abbott Park, IL 60064 Test method change for quantitating Anti-D and Anti-Y monoclonal antibodies which are used in the testing of the recombinant HBsAg subtype Ad (Code 98034) and HBsAg subtype Ay (Code 98035) antigens used in the ARCHITECT HBsAg and HBsAg Confirmatory assays.
P060011/S001

3/31/11

C-flex Intraocular Lens Rayner Intraocular Lenses Limited

East Sussex, England, U.K.

BN37AN

Alternative optical measurement equipment.
P060027/S030

3/31/11

Situs OTW UW28D Lead ELA Medical, Inc. Plymouth, MN

55441

Update to the current leads label printing software.
P060030/S017

3/22/11

COBAS AmpliPrep/ COBAS TaqMan HCV Test and COBAS TaqMan HCV Test for use with The High Pure System, v2.0 Roche Molecular Systems, Inc.

Pleasanton, CA 94588

Discontinuation of Final Bulk Testing requirements for bulk Quantitation Standard (QS) and Internal Control (IC) reagents for 17 QS/IC products used with the associated assays.
P060039/S022

3/30/11

Attain StarFix Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P070007/S028

3/3/11

Talent Thoracic Stent Graft System Medtronic Vascular Santa Rosa, CA

95403

Addition of a lubricant during assembly of the Captiva Delivery System.
P070007/S030

3/18/11

Talent Thoracic Stent Graft System with Captiva Delivery System Medtronic Ireland

Galway, Ireland

Transfer of post sterilization inspections to an alternate site.
P070015/S056

3/3/11

XIENCE V® Everolimus Eluting Coronary Stent System Abbott Vascular Temecula, CA

92591

Change to the coating manufacturing process.
P070015/S059

3/18/11

XIENCE V® and PROMUS Everolimus Eluting Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change in resin verification at receiving inspection.
P070022/S012

3/9/12

Adiana Permanent Contraception System Hologic, Inc.

Marlborough, MA

01752

Addition of a manufacturing step for the Adiana matrix component.
P080006/S020

3/30/11

Attain Ability Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P090003/S009

3/9/11

Express™ LD Iliac Premounted Stent System Boston Scientific Maple Grove, MN

55311

Modification in the balloon wingfolding operation during manufacture of the device.
P090003/S010

3/18/11

Express LD Iliac Premounted Stent Systems Boston Scientific Corporation

Maple Grove, MN

55311

Change in bacterial endotoxin test methodology.
P090006/S005

3/18/11

Complete SE Vascular Stent System Medtronic Ireland

Galway, Ireland

Transfer of post sterilization inspections to an alternate site.
P090013/S001

3/18/11

REVO MRI™ SureScan® Pacing System Medtronic, Inc.

Mounds View, MN

55112

Multiple changes in suppliers of various electronic components.
P090013/S002

3/17/11

REVO MRI™ SureScan® Pacing System Medtronic, Inc. Mounds View, MN 55112 Update to the sterile packaging operation process.
P090013/S003

3/25/11

REVO MRI™ SureScan® Pacing System Medtronic, Inc.

Mounds View, MN

55112

Upgrades to various manufacturing process software versions.
P090013/S004

3/30/11

CapSure Fix Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P090013/S005

3/28/11

REVO MRI™ SureScan® Pacing System Medtronic, Inc.

Mounds View, MN 55112

Changes to align production with existing processes used in other marketed devices.
P090013/S007

3/31/11

Revo MRI™ SureScan® Pacing System Medtronic, Inc.

Mounds View, MN 55112

Revising parameters to an epoxy dispense manufacturing process.
P090013/S008

3/31/11

Revo MRI IPG Medtronic, Inc.

Mounds View, MN

55112

Addition of a new equipment controller for the print label files.
P100010/S003

3/9/11

Arctic Front Cardiac CryoAblation Catheter Medtronic Cryocath LP

Quebec, Canada

H9R 5ZB

Change of the adhesive used to seal the vacuum tube to rear strain.
P100021/S005

3/16/11

Endurant® Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Addition of an automated crimping machine used during the radiopaque marker- band bond process of the Endurant Delivery System.
P100021/S006

3/18/11

Endurant® Stent Graft System Medtronic Ireland Galway, Ireland Transfer of post sterilization inspections to an alternate site.
P100021/S007

3/18/11

Endurant® Stent Graft System Medtronic Ireland Galway, Ireland Improvements upon the current process for stent graft loading.

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 89

Summary of PMA Originals Under Review

Total Under Review: 96

Total Active: 47

Total On Hold: 49

Number Greater Than 180 Days: 4

Summary of PMA Supplements Under Review

Total Under Review: 654

Total Active: 457

Total On Hold: 197

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 3

Supplements: 97

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 89

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 210.8

FDA Time: 122.4 Days MFR Time: 88.4 Days

SOURCE

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading