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PMA Final Decisions Rendered for January 2005

P030052

1/24/05

UroVysion™ Bladder Cancer Kit

Vysis, Inc.

Downers Grove , IL

60515

Approval for the UroVysion™ Bladder Cancer Kit. The device is indicated for: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

P040014

1/14/05

IBI Therapy ™Cardiac Ablation System

Irvine Biomedical

Irvine , CA

92614

Approval for the IBI Therapy Cardiac Ablation System. The device is indicated for mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.

P870072/S030

1/19/05

Real-Time

Thoratec® Implantable Ventricular Assist Device (IVAD)

Thoratec Corporation

Pleasanton , CA

94588

Approval for a modified IVAD tunneled pneumatic fitting and to add two (2) cannulae for the IVAD device; IVAD Curved Short Arterial Cannula and IVAD Short Ventricular Cannula with 2 Side Holes.

P910023/S075

1/19/05

180-Day

Cadence Tiered-Therapy Defibrillation System (V-239T, V-196T, V-242, V-243, V-193, V-193C, V-233, V-239, V-236, V-196, V-235, V-197, V-240, V-199)

St. Jude Medical

Sunnyvale , CA

94086

Approval for labeling modifications to describe the protocol and results from the DEFINITE clinical trial.

P960009/S030

1/14/05

180-Day

Medtronic Activa® Parkinson’s Control Therapy

Medtronic Neurological Regulatory Affairs

Minneapolis , MN

55432

Approval for a revised post-approval study for the device.

P960011/S009

1/27/05

180-Day

BioLon™

Savient Pharmaceuticals, Inc.

East Brunswick , NJ

08816

Approval for a change in manufacturing site to the Bio-Technology General, Ltd. Facility in Be’er Tuvia, Israel , and for a change in the specifications for the active pharmaceutical product in BioLon.

P970021/S012

1/3/05

Special

GYNECARE THERMACHOICE III Uterine Balloon Therapy System

Ethicon, Inc.

Somerville , NJ

08876

Approval for changes to the Instructions for Use, Operating Manual and Controller Pull-Out Card.

P970051/S029

1/19/05

180-Day

Nucleus 24 Cochlear Implant System

Cochlear Americas

Englewood , CO

80112

Approval for a new injection-moulded ceramic feedthrough component and its related manufacturing processes.

P970058/S021

1/5/05

Real-Time

ImageChecker D

R2 Technology, Inc.

Sunnyvale , CA

94087

Approval to expand the use of the ImageChecker D to allow computer aided detection (CAD) processing of full-flied digital mammography (FFDM) images acquired with the Siemens Novation FFDM system.

P990004/S007

1/7/05

180-Day

SURGIFOAM Absorbable Gelatin Sponge, U.S.P.

Johnson and Johnson Wound Management

Somerville , NJ

08876

Approval for a new sterilization site located at Isotron PLC, Swindon , United Kingdom .

P000006/S005

1/12/05

Real-Time

Titan™ Inflatable Penile Prosthesis

Mentor Corporation

Santa Barbara , CA

93111

Approval for the addition of an adapter to the rear tip extenders included in the assembly kit.

P020014/S008

1/31/05

Real-Time

Essure System

Conceptus, Inc.

San Carlos , CA

94070

Approval for a proposed packaging modification and subsequent changes to the ethylene oxide (EO) sterilization cycle and shelf life validation study.

P030017/S003

1/19/05

Real-Time

PRECISION™ Spinal Cord Stimulation (SCS) System

Advanced Bionics

Sylmar , CA

91342

Approval for changes to the lead assembly.

P030017/S004

1/21/05

Special

PRECISION™ Spinal Cord Stimulation (SCS) System

Advanced Bionics

Sylmar , CA

91342

Approval for labeling changes.

P030035/S002

1/14/05

180-Day

St. Jude Frontier ™ Biventricular Cardiac Pacing System including the Frontier ™ Model 5508 and 5508L Pulse Generators, the Aescula ™ LV Model 1055K Lead,

and the Model 3307 v4.4.2m Programmer Software for use with the Model

3500/3510 Programmer

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval of the post-approval study for your device.

P030054/S002

1/14/05

180-Day

St. Jude Medical ® Epic ™ HF System including the Epic ™ HF Model V-338 Cardiac Resynchronization Therapy Defibrillator, the Aescula ™ LV Model 1055K Lead, the QuickSite ™ LV Model 1056K Lead, and the Model 3307 v4.5m Programmer Software; St. Jude Medical ® Atlas ® + HF System including the Atlas ® + HF Model V-340 Cardiac Resynchronization Therapy Defibrillator, the Aescula ™ LV Model 1055K Lead, the QuickSite ™ LV Model 1056K Lead, and the Model 3307 v4.5m Programmer Software

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval of the post-approval study for your device.

N16420/S007

1/3/05

Mentor Polytef Paste for Injection

Mentor Corporation

Santa Barbara , CA

93111

Change in vendor of a raw material for Polytef Paste for Injection.

P810046/S218

1/14/05

CrossSail® Coronary Dilatation Catheters, OpenSail® Coronary Dilatation Catheters,

RX Chassis I™ Coronary Dilatation Catheters, Voyager™ OTW Coronary Dilatation Catheters, Voyager™ RX Coronary Dilatation Catheters, and

RX Chassis III™ Coronary Dilatation Catheters

Guidant Corporation

Temecula , CA

92591

Manufacturing process change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (Parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release).

P860057/S025

1/19/05

Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900P (PERIMOUNT Plus™), and 6900PTFX

Edwards LifeSciences, LLC

Irvine , CA

92614

Change in the supplier of the knitting operation of the polyester fabric.

P870024/S045

1/7/05

FluoroPerm® 60 – Rigid Gas Permeable Contact Lenses

Paragon Vision Sciences

Mesa , AZ

85204

Modification of a specific process of manufacture to reduce the hydration time and improve the comfort for the contact lens user.

P870056/S018

1/19/05

Carpentier-Edwards® Bioprosthesis, Models 2625 and 6625

Edwards LifeSciences, LLC

Irvine , CA

92614

Change in the supplier of the knitting operation of the polyester fabric.

P870077/S016

1/19/05

Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625L and 6625-ESR-LP

Edwards LifeSciences, LLC

Irvine , CA

92614

Change in the supplier of the knitting operation of the polyester fabric.

P890043/S038

1/14/05

Flexi-Cut® Directional Debulking System

Guidant Corporation

Temecula , CA

92591

Change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release).

P900039/S015

1/24/05

Collagraft Strip Bone Graft Matrix

NeuColl, Inc.

Wilmington , NC

28405

Change in the final product testing from rabbit pyrogenicity test to a Limulus Amebocyte Lysate (LAL) gel-clot test for determining the presence of endotoxins.

P920047/S025

1/10/05

Blazer II Cardiac Ablation Catheter

Boston Scientific Corporation

San Jose , CA

95134

Change in the torque hole adhesive cure time.

P930031/S023

1/14/05

Wallstent® (Iliac, TIPS, Venous) Endoprosthesis with Unistep™ Plus Delivery System

Boston Scientific Corporation

Maple Grove , MN

55311

Changes in the manufacturing process: 1) Introduction of a Tip Tug Test on-line at the final inspection step, 2) Introduction of an automated auto-feed system to the existing Swager unit, and 3) Introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process.

P940019/S018

1/14/05

Wallstent® (Iliac, TIPS, Venous) Endoprosthesis with Unistep™ Plus Delivery System

Boston Scientific Corporation

Maple Grove , MN

55311

Changes in the manufacturing process: 1) Introduction of a Tip Tug Test on-line at the final inspection step, 2) Introduction of an automated auto-feed system to the existing Swager unit, and 3) Introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process.

P970027/S004

1/31/05

Abbott AxSYM® Anti-HCV (List Number 5C36)

Abbott Laboratories

Abbott Park , IL

60064

Change in the manufacture and testing flow of Index Calibrator.

P980033/S012

1/14/05

Wallstent® (Iliac, TIPS, Venous) Endoprosthesis with Unistep™ Plus Delivery System

Boston Scientific Corporation

Maple Grove , MN

55311

Changes in the manufacturing process: 1) Introduction of a Tip Tug Test on-line at the final inspection step, 2) Introduction of an automated auto-feed system to the existing Swager unit, and 3) Introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process.

P000007/S005

1/19/05

Edwards Prima Plus Stentless Bioprosthesis Model 2500P

Edwards LifeSciences, LLC

Irvine , CA

92614

Change in the supplier of the knitting operation of the polyester fabric.

P010041/S005

1/19/05

Carpentier-Edwards® Supraannular (S.A.V.®) Bioprosthesis, Model 2650

Edwards LifeSciences, LLC

Irvine , CA

92614

Change in the supplier of the knitting operation of the polyester fabric.

P020025/S008

1/10/05

Blazer II XP Cardiac Ablation Catheter

Boston Scientific Corporation

San Jose , CA

95134

Change in the torque hole adhesive cure time.

P030026/S003

1/4/05

Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Removal of in process calibrator testing.

P030026/S004

1/14/05

Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Modification to the microwell coating specification.