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PMA Final Decisions Rendered for November 2004

P030007

11/23/04

Kodak Mammography CAD Engine

Eastman Kodak Company

Rochester , NY

14650

Approval for the Kodak Mammography CAD Engine. The Kodak Mammography CAD Engine is a software package intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the software assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

P030031

11/5/04

Biosense Webster NaviStar™/

Celsius™ ThermoCool® Diagnostic/

Ablation

Deflectable Tip Catheters

Biosense Webster, Inc.

Diamond Bar , CA

91765

Approval for the NaviStar™/

Celsius™ ThermoCool® Deflectable Diagnostic/Ablation Catheters, which include these models: NaviStar™ ThermoCool® (models NS75T-BCT-252-HS, NS75T-CCT-252-HS, NS75T-DCT-252-HS, NS75T-FCT-252-HS, NS75TC-BCT-252-HS, NS75TC-CCT-252-HS, NS75TC-DCT-252-HS, and NS75TC-FCT-252-HS); and Celsius™ ThermoCool® (models D7IT-BL-252-RT, D7IT-DL-252-RT, D7IT-FL-252-RT, D7ITC-BL-252-RT, D7ITC-DL-252-RT, and D7ITC-FL-252-RT). The Biosense Webster NaviStar™/Celsius™ ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the Stockert 70 generator, for the treatment of Type I atrial flutter in patients age 18 or older. The NaviStar™ ThermoCool® catheter provides location information when used with the Carto EP/XP Navigation System.

P040022

11/3/04

EVS™ Vascular Closure System

angio LINK Corporation

Taunton , MA

02780

Approval for the EVS Vascular Closure System. The device is indicated for percutaneous femoral artery approximation. The EVS vascular Closure System is also indicated to reduce time to hemostasis at femoral puncture sites and to reduce time to ambulation for patients undergoing diagnostic and interventional catheterization procedures using 6-8 French procedural sheaths.

P880086/S101

11/22/04

Real-Time

Identity/Identity ADx, Infinity and Integrity families of pacemakers

St. Jude Medical Cardiac Rhythm Management Division

Sylmar , CA

91342

Approval for the following: 1) a firmware modification to the Identity/Identity ADx family of pacemakers to correct a potential condition that would result in hardware back-up VVI pacing; and 2) a component design change to Identity/Identity ADx, Infinity and Integrity family of pacemakers modifying the printed circuit board used to connect the feedthrough to the pacemaker circuitry.

P930038/S041

11/4/04

Real-Time

Angio-Seal™ Vascular Closure Device STS PLUS

St. Jude Medical, Inc.

Minnetonka , MN

55345

Approval for a new anchor design. The device, as modified, will be marketed under the trade name AngioSeal Vascular Closure Device STS PLUS.

P950037/S038

11/10/04

180-Day

Selox ST/JT Steroid-Eluting Passive-Fixation Endocardial Packing Lead Models Selox ST 53, Selox ST 60, Selox JT 45, and Selox JT 53

Biotronik, Inc.

Lake Oswego , OR

97035

Approval for the addition of a drug collar to the pacing lead. The device, as modified, will be marketed under the trade name Selox ST/JT and is indicated as follows: Selox ST and Selox JT steroid eluting leads are designed for use with implantable pulse generators that require pacing leads with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class I definition of the ACC/AHA/NASPE Task Force Report, entitled “ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)” ( Gregoratos et al. 2002).

P970004/S030

11/24/04

180-Day

Medtronic InterStim® Tined Lead

Medtronic Gastroenterology and Urology (MGU)

Shoreview , MN

55126

Approval for modification of the informed consent document, case report forms, the investigator agreement, and the voiding diary.

P980043/S005

11/18/04

Real-Time

Mosaic Porcine (Model 305) and Hancock II (Model T505) Bioprostheses

Medtronic Heart Valves

Santa Ana , CA

92705

Approval for additional product lines of the Mosaic Porcine Bioprosthesis and the Hancock II Bioprosthesis which will use smaller sewing ring diameters.

P980049/S016

11/17/04

135-Day

Alto 2 Implantable Cardioverter Defibrillator Models 624 and 625

ELA Medical, Inc.

Plymouth , MN

55441

Approval for changes to the Alto 2 ICD low-power module and final device assembly process performed at ELA Medical, S.A.

P990001/S016

11/22/04

Real-Time

Selection AFm, Vitatron C60 DR, C20 SR, T60 DR , and T20 SR Pacing Systems

Vitatron

Minneapolis , MN

55432

Approval for software revisions.

P990064/S010

11/18/04

Real-Time

Mosaic Porcine (Model 305) and Hancock II (Model T505) Bioprostheses

Medtronic Heart Valves

Santa Ana , CA

92705

Approval for additional product lines of the Mosaic Porcine Bioprosthesis and the Hancock II Bioprosthesis which will use smaller sewing ring diameters.

P000025/S014

11/17/04

180-Day

MED-EL COMBI 40+ Cochlear Implant System PULSARCI 100 Cochlear Implant

MED-EL Corporation

Durham , NC

27713

Approval for the PULSARCI 100 Cochlear Implant, a member of COMBI C40+ Cochlear Implant System.

P000029/S010

11/2/04

Real-Time

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Princeton , NJ

08540

Approval for modification of the parent/patient brochure.

P000029/S011

11/12/04

Real-Time

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Princeton , NJ

08540

Approval for an increase in the shelf life of DX-10 from 6 months to 12 months.

P000032/S005

11/9/04

180-Day

Her Option™ Cryoablation Therapy System

American Medical Systems, Inc.

Minnetonka , MN

55343

Approval for a revised User’s Manual and Package Insert which reflects the results of the long term follow-up of study subjects and a quick reference guide.

P010012/S032

11/24/04

Real-Time

EASYTRAK® 3 IS-1 Lead Models: 4548/4549/4550

Guidant Corporation

St. Paul , MN

55112

Approval for change of lead connector from LV-1 to IS-1.

P010032/S012

11/9/04

180-Day

Genesis Neurostimulation System

Advanced Neuromodulation Systems, Inc.

Plano , TX

75024

Approval for the Genesis RC Neurostimulation System, model 3708, and the Genesis RC Dual (IPG) System, model 3744, which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

P010055/S002

11/5/04

180-Day

CoreTherm™ System Microwave Thermotherapy

Prostalund Operations AB

Lund , Sweden

SE-226 60

Approval for a manufacturing site located at MRI Manufacturing and Research Inc (MRI Medical), 4700 S. Overland Drive , Tucson , Arizona 85714-3430 . MRI Medical will duplicate manufacture the modified Prostalund® Feedback Treatment® (PLFT®) catheter.

P010068/S005

11/16/04

180-Day

Celsius™ DS 8 mm Diagnostic/Ablation Tip Catheter

Biosense Webster, Inc.

Diamond Bar , CA

91765

Approval for a manufacturing site located at Biosense Webster, Inc., Chihuahua , Mexico .

P020026/S005

11/17/04

Special

CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System

Cordis Corporation

Miami Lakes , FL

33102

Approval for an additional 500X visual inspection prior to crimping.

P020030/S001

11/22/04

180-Day

Stelix steroid eluting pacing leads models BR44D;

Stelix II steroid eluting pacing leads model BRF24D, EasyTurn, BRF25D EasyTurn and BRF26D EasyTurn;

EasyTurn Accessory Stylet Kits BRF24D, BRF25D and BRF26D

ELA Medical, Inc.

Plymouth , MN
55441

Approval for the introduction of the EasyTurn Deployment mechanism. The device, as modified, will be marketed under the trade name Stelix II EasyTurn and is indicted for use with an implantable pacemaker. They are intended for permanent pacing and sensing of the atrium.

P030025/S008

11/22/04

Special

TAXUS™ Express2™ Coronary Stent System

Boston Scientific Corporation

Maple Grove , MN

55311

Approval for addition of specifications for the DVT visual inspection that is conducted after the cone-puff procedure.

P030032/S002

11/12/04

180-Day

Captique Injectable Gel

Genzyme Corporation

Cambridge , MA

01242

Approval for a new source of hyaluronic acid obtained from bacterial fermentation. The device, as modified, will be marketed under the trade name Captique and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

P030054/S001

11/17/04

180-Day

St. Jude Medical® Epic™ HF Defibrillator Model V-337, St. Jude Medical® Atlas®+ HF Defibrillator Model V-343

St. Jude Medical, Inc.

Sunnyvale , CA

94086

Approval for the addition of a programmable interventricular pace delay feature to the currently market-approved CRT-D devices.

P800019/S011

11/19/04

CYBERLITH®

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P820022/S003

11/19/04

CYBERTACH

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P830026/S078

11/19/04

COSMOS

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P830060/S056

11/19/04

VENTAK, BIPOLAR ENDOCARDIAL

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P840068/S042

11/19/04

DELTA®, VISTA®

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P860004/S063

11/12/04

Medtronic® SynchroMed® II Implantable Programmable Infusion Pump System

Medtronic, Inc.

Minneapolis , MN

55432

Updating the Final Functional Test software to reduce human data entry errors and adding an additional equipment interface to avoid calibration constant entry errors by manufacturing operators.

P860007/S022

11/19/04

INTERTACH

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P870072/S031

11/17/04

Thoratec® Ventricular Assist Device (VAD) System

Thoratec Corporation

Pleasanton , CA

94588

Change in th joining process for the paracorporeal Ventricular Assist Device (PVAD) case fittings and a change from a machining process to an injection molding process for the manufacture of PVAD components.

P890061/S015

11/19/04

VENTAK P

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P910020/S025

11/19/04

RELAY

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P910073/S048

11/19/04

ENDOTAK®, ENDOTAK ENDURANCE, ENDOTAK RELIANCE®

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P910077/S047

11/19/04

VENTAK PRx, VENTAK MINI

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P930035/S013

11/19/04

VENTAK P2, VENTAK P3

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P940008/S019

11/19/04

RES-Q

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P940031/S032

11/19/04

VIGOR, DISCOVERY®, MERIDIAN®

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P950001/S012

11/19/04

SELUTE, SELUTE PICOTIP

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P960004/S026

11/19/04

FINELINE®, FINELINE® II

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P960006/S012

11/19/04

SWEET TIP Rx, SWEET PICOTIP Rx, FLEXTEND®

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P960040/S048

11/19/04

VENTAK AV, VENTAK VR, VENTAK PRIZM® VITALITY®, VITALITY® 2

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

D970003/S030

11/19/04

PULSAR®, PULSAR® MAX, INSIGNIA®

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P000012/S004

11/4/04

COBAS AMPLICOR HCV Test, version 2.0

Roche Molecular System, Inc.

Pleasanton , CA

94566

Elimination of in-process testing proven as redundant.

P000014/S010

11/4/04

VITROS Immunodiagnostic Products

Anti-HBs Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Addition of new reagent dispensing equipment.

P000044/S004

11/4/04

VITROS Immunodiagnostic Products

Anti-HBsAg Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Addition of new reagent dispensing equipment.

P010012/S034

11/19/04

CONTAK CD, CONTAK CD 2, EASYTRAK®, EASYTRACK® 2, EASYTRAK® 3, CONTAK RENEWAL®, CONTAK RENEWAL® 3

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P010021/S004

11/4/04

VITROS Immunodiagnostic Products

Anti-HCV Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Addition of new reagent dispensing equipment.

P020009/S018

11/30/04

Express 2 ™ Stent Delivery System

Boston Scientific Corporation

Maple Grove , MN 55311

Addition of an alternative supplier of stainless steel used in the manufacture of stent components.

P030005/S004

11/19/04

CONTAK RENEWAL® TR

Guidant Corporation

St. Paul , MN

55112

Change to the procedures for inspections of materials/ components received from suppliers.

P030024/S002

11/4/04

VITROS Immunodiagnostic Products

Anti-HBc Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Addition of new reagent dispensing equipment.

P030025/S011

11/30/04

Taxus® Express 2 ™ Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove , MN 55311

Change in the bacterial endotoxin test used as part of the finished device testing.

P030025/S012

11/30/04

Taxus® Express 2 ™ Stent Delivery System

Boston Scientific Corporation

Maple Grove , MN 55311

Addition of an alternative supplier of stainless steel used in the manufacture of stent components.

P030026/S002

11/4/04

VITROS Immunodiagnostic Products

Anti-HBc IgM Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester , NY

14626

Addition of new reagent dispensing equipment.