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PMA Final Decisions Rendered for April 2002

P000033

4/3/02

IntraCoil® Self-expanding Peripheral Stent

Sulzer IntraTherapeutics, Inc.

St. Paul, MN

55112

Approval for the IntraCoil® Self-expanding Peripheral Stent. This device is indicated for improving peripheral luminal diameter in patients with symptomatic atherosclerotic disease due to stenotic lesions (length ≤ 15 cm) or occlusive lesions (length ≤ 12 cm) in femoropopliteal arteries, to the bifurcation of the tibial artery, with a reference vessel diameter of 3.0 to 7.8 mm.

P010018

4/11/02

ViewPoint™ CK System

Refractec, Inc.

Irvine, CA

92618

Approval for the Refractec™ ViewPoint™ CK System. This device is indicated for: Temporary reduction of spherical hyperopia in patients who have 0.75 D to 3.25 D of cycloplegic spherical hyperopia, less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), a cycloplegic spherical equivalent of 0.75 D to 3.00 D, and are 40 years of age or greater with a documented stability of refraction for the prior 12 month, as demonstrated by a change of less than 0.50 D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction.

P790017/S076

4/19/02

180-Day

Medtronic Stormer Over-the-Wire Balloon Dilatation Catheter

Medtronic AVE, Inc.

Santa Rosa, CA 95403

Approval for the Medtronic Stormer Over-the-Wire Balloon Dilatation Catheter.

P790018/S041

4/23/02

180-Day

Medtronic Hall Aortic Valved Collagen Impregnated Conduit, Model Z7700, and Medtronic Hall Rotatable Aortic Valved Collagen Impregnated Conduit, Model R7700

Medtronic, Inc.

Minneapolis, MN 55432

Approval for a change to the country of origin for the collagen used in these products. The intent of the change is to source the collagen from a country that is free from Bovine Spongiform Encephalopathy (BSE).

P790018/S043

4/9/02

180-Day

Medtronic Hall Rotatable Aortic Valved Collagen Impregnated Conduit prosthesis (Model R7700)

Medtronic Heart Valves

Minneapolis, MN

55432

Approval for an alternate manufacturing facility located at Medtronic, Spring Lake Park, Minnesota. Manufacturing operations related to fabrication of the sewing ring, attachment of the conduit and sewing ring to the disc and housing subassembly, and sterile and final packaging processes for the Medtronic Hall Rotatable Aortic Valved Collagen Impregnated Conduit Prosthesis (Model R7700) will be performed at this facility.

P850010/S017

4/3/02

Real-Time

Helistat®/Helitene® Absorbable Collagen Hemostatic Agents

Interga LifeSciences Corporation

Plainsboro, NJ

08536

Approval for the marketing of the Helitene® fibrils, in a pad form.

P860003/S040

4/12/02

Special

UVAR® XTS™ Photopheresis System

THERAKOS, a Johnson and Johnson Company

Exton, PA

19341

Approval for a labeling change (inclusion of an additional warning) to address the potential for the development of hypovolemia and hypotension during photopheresis treatments in patients with elevated triglyceride levels (hyperlipidemia), such as patients receiving certain cutaneous T-cell lymphoma drugs, like Targretin® (Bexarotene).

P870072/S018

4/18/02

180-Day

Thoratec Ventricular Assist Device (VAD) System

Thoratec Corporation

Pleasanton, CA

94588

Approval for upgrading the embedded software (firmware) for the TLC-II Portable VAD Driver from Version 4.03 to Version 4.11.

P870072/S019

4/18/02

Special

Thoratec Ventricular Assist System

Thoratec Corporation

Pleasanton, CA

94588

Approval for addition of a CAUTION statement to the package labeling.

P880003/S084

4/16/02

180-Day

RAPTORRAIL™ PTCA Dilatation Catheter

Cordis Corporation

Warren, NJ

07059

Approval for an alternate manufacturing facility located at Cordis de Mexico SA de CV, Chihuahua, Mexico.

P900033/S008

4/19/02

Panel

INTEGRA® Dermal Regeneration Template

INTEGRA LifeSciences Corporation

Plainsboro, NJ

08536

Approval for the INTEGRA® Dermal Regeneration Template. This device is indicated for "the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra Dermal Regeneration Template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient."

P900043/S030

4/29/01

180-Day

Bx Sonic Balloon Expandable Stent OTW Delivery System

Cordis Corporation

Miami, FL

33102

Approval for the Bx Sonic Balloon Expandable Stent OTW Delivery System. The device, as modified, is indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (≤30 mm in length) with reference diameters in the range of 2.25 mm to 4.00 mm. The 2.25 mm, 2.5 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.

P900060/S023

4/30/02

180-Day

Carbomedics Prosthetic Heart Valve (CPHV) products: Standard Aortic (Model A500), Standard Mitral (Model M700), and Reduced Aortic (Model R500)

Sulzer Carbomedics, Inc.

Austin, TX

78752

Approval for the removal of the Biolite® carbon coating from the sewing cuff of the above referenced products.

P910018/S002

4/9/02

180-Day

Liposorber® LA-15 System

Kaneka Pharma America Corp.

New York, NY

10022

Approval for modifications to the Patient Registry/Post-market Study of the Liposorber® LA-15 System.

P920047/S015

4/18/02

180-Day

EPT-1000 Cardiac Ablation System

SP Technologies, Inc.

San Jose, CA

95134

Approval for new indications for use for one device component of the EPT-1000 Cardiac Ablation System. The device component, as modified, will, be marketed under the trade name EPT-1000 TC™ Cardiac Ablation Controller with Temperature control and is indicated for use in conjunction with the appropriate radiofrequency ablation catheter for cardiac ablation procedures.

P940015/S007

4/26/02

Special

Synvisc® (hylan G-F 20)

Genzyme Biosurgery

Cambridge, MA

02139

Approval for the addition of the following statement to the Synvisc Physician Package Insert: "Precaution: Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the tip of the syringe."

P940022/S020

4/23/02

Real-Time

BTE (Behind-The-Ear) T-Mic™ and HiFocus I Surgical Instruction Video (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the BTE T-Mic, and in-the-ear microphone accessory item to be offered for use with the BTE Sound Processor, and approval of the HiFocus I Surgical Instruction Video, which will be distributed as part of the Surgeon’s Kit.

P950019/S012

4/2/02

Real-Time

Ray Threaded Fusion Cage (TFC™) and Ray TFC Unite™ Devices with instrumentation

United States Surgical

Norwalk, CT

06856

Approval for additional instruments for the ALIF-open surgical technique for the Ray TFC™ Ray TFC Unite™ Devices and revised labeling.

P950032/S031

4/9/02

Real-Time

Apligraf

Organogenesis, Inc.

Canton, MA

02021

Approval for revisions in the product labeling including inclusion of a statement concerning the virus testing for each donor cell strain.

P950037/S023

4/2/02

Real-Time

Philos DR-T Pulse Generator and

B-K00.T.U Programmer Software

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for changes to the pulse generator to allow transmission of diagnostic information, and for changes to the programmer software. The device, as modified, will be marketed under the trade name Philos DR-T Pulse Generator and

B-K00.T.U Programmer Software, and has the same indications as the currently marketed Philos Dr. Specifically: 1) Rate adaptive pacing with Philos DR-T pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.

2) Indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e., bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third-degree AV block, and carotid sinus syndrome. 3) Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances and tachyarrhythmias that are suppressed by chronic pacing.

P960011/S008

4/1/02

180-day

BioLon™ (1% sodium hyaluronate for Ophthalmic Surgery)

Bio-Technology General Corp.

Iselin, NJ

08830

Approval for an alternate sterilization and final cartoning facility located at Medical Manufacturing Corporation, Erie, Pennsylvania.

P960043/S038

4/29/02

Real-Time

Closer II 6Fr. Suture-Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for a design change to the Suture Trimmer™, an accessory device to the Closer™ Systems previously approved under PMAs P960043/S027 and S032. The device, as modified, will be marketed under the trade name Suture Trimmer and is indicated, as an accessory device, for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic and interventional catheterization procedures using 5 to 6 Fr. Sheaths. The Closer II 6 Fr. SMC System reduces the time to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions.

P960058/S020

4/23/02

Real-Time

BTE (Behind-The-Ear) T-Mic™ and HiFocus I Surgical Instruction Video (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the BTE T-Mic, and in-the-ear microphone accessory item to be offered for use with the BTE Sound Processor, and approval of the HiFocus I Surgical Instruction Video, which will be distributed as part of the Surgeon’s Kit.

P970008/S020

4/10/02

Real-Time

Targis™ System

Urologix, Inc.

Minneapolis, MN

55447

Approval for changes to the "Contraindications" and Precautions" sections of the labeling.

P970035/S028

4/29/02

180-day

Thunder™ High Scaffolding Over-the-Wire and Rapid Exchange Saphenous Vein Graft Stent Systems

Medtronic AVE

Santa Rosa, CA

95403

Approval for the Thunder™ High Scaffolding Over-the-Wire (OTW) and Rapid Exchange (RX) Saphenous Vein Graft (SVG) Stent Systems; the addition of a new manufacturing facility, AVE Ireland Limited, Galway, Ireland; and the addition of a new contract sterilizer, Iotron EBIS Industries UK, Ltd., Oxfordshire, United Kingdom. The devices, will be marketed under the trade names of the Thunder™ High Scaffolding OTW and RX SVG Stent Systems, and are indicated for improving vessel luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions (length ≤ 40 mm) in saphenous vein grafts with reference vessel diameters between 3.0 mm and 5.0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present. The RX delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone PTCA perfusion catheter.

P970035/S033

4/24/02

135-Day

Medtronic AVE S7 with Discrete Technology™ Over-the-Wire Coronary Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for the addition of an optional mechanical fixation step to the stent securement process. The device, as modified, will be marketed under the trade name S7 with Discrete Technology™ Over-the-Wire Coronary Stent System and is indicated for the improvement of coronary luminal diameter.

P970058/S013

4/24/02

Real-Time

ImageChecker M1000

R2 Technology, Inc.

Sunnyvale, CA

94087

Approval for the addition of "SmartView", a feature that enables a user to see with more detail the region underlying a marker placed on a mammogram display.

P980009/S011

4/12/02

180-Day

Boston Scientific Scimed Magic Wallstent® Endoprosthesis with

Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a modification to a process step in which the Magic Wallstent® device tip is insert-molded onto the inner catheter shaft rather than adhesively attached.

P980016/S028

4/16/02

Real-Time

Model 2490A CareLink Monitor and Device Data Management Application (DDMA) Software Model 2491 Version 1.0

Medtronic, Inc.

Minneapolis, MN

55432

Approval for expansion of the functionality of the Model 2490A CareLink monitor and Model 2491 software, Version 1.0 to include the GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR and GEM III DR implantable cardioverter defibrillators.

P980023/S008

4/24/02

Real-Time

Belos VR-T ICD with Programmer Software

(I-K01.0.A/5)

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Belos VR-T ICD Home Monitoring System. The device, as modified, will be marketed under the trade name Belos VR-T ICD with Programmer Software

(I-K01.0.A/5) and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

P980043/S001

4/16/02

Special

Hancock II® Porcine Bioprosthesis, Models T505 and T510

Medtronic, Inc.

Santa Ana, CA

92705

Approval to revise one caution statement and to include references to a new valve handle (Model 7639) within the Instructions for Use.

P990017/S030

4/24/02

Panel Track

ANCURE® Aortoiliac System

Guidant Corporation

Menlo Park, CA

94025

Approval for the ANCURE® Aortoiliac System. This device is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients whose anatomy does not allow the use of a tube or bifurcated device.

P990037/S009

4/3/02

Real-Time

Duett Sealing Device (Model 1000) and the Diagnostic Duett Sealing Device (Model 2200)

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for a design change to the Duett Sealing Device and Diagnostic Duett Sealing Device. Specifically, a Relief Valve component will replace the Pilot Balloon Assembly on both devices.

P990037/S010

4/30/02

180-Day

Vascular Solutions Diagnostic Duett™ Sealing Device, Model 2200

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for changing the supplier from Cook Pharmaceuticals to Chesapeake Biological Laboratories. This change will also affect the approved diluent. Specifically, the current approved buffering agent component, 0.1% Trolamine NF (TEA) will be changed to 0.1% Tromethamine USP (TRIS).

P990052/S007

4/17/02

Real-Time

Vibrant Soundbridge Direct Drive Demonstrator

Symphonix Devices, Inc.

San Jose, CA

95131

Approval for the addition of the Direct Drive Demonstrator to the Vibrant Soundbridge System. The device, as modified, will be marketed under the trade name Vibrant Soundbridge Direct Drive Demonstrator. The indications for use for the device have not changed.

P990066/S007

4/12/02

180-Day

Senographe 2000D Full Field Digital Mammography System

General Electric Medical Systems

Milwaukee, WI

53201

Approval for modifications to the system to permit integration and use of the ImageChecker® M1000-DM Computer Aided Detection (CAD) system manufactured by R2 Technology, Inc.

P000027/S001

4/29/02

180-Day

Elecsys® Free PSA Immunoassay

Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for the addition of the Elecsys® Free PSA assay to the MODULAR ANALYTICS E170 Immunoassay Analyzer. The device, as modified, will be marketed under the trade name Elecsys® Free PSA Immunoassay, Elecsys® Free PSA CalSet and Elecsys Free PSA CalCheck and are indicated as follows: Immunoassay for the in vitro quantitative determination of free prostate-specific antigen in human serum and plasma. The Elecsys Free PSA Immunoassay is indicated for measurement of fPSA in conjunction with the Elecsys Total PSA to develop a ratio (% fPSA) of fPSA to tPSA. This ratio is useful when used in conjunction with the Elecsys Total PSA test as an aid in distinguishing prostate cancer from benign prostate conditions in men age 50 years or older who have a digital rectal examination (DRE) that is not suspicious for prostate cancer and an Elecsys Total PSA value in the range 4-10ng/ml. Prostate biopsy is required for the diagnosis of prostate cancer. The Electrochemilumi-nescence Immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) Immunoassay analyzers. Elecsys Free PSA CalSet is used for calibrating the quantitative Elecsys Free PSA assay on the Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay systems. Free PSA CalCheck is for use in the verification of the calibration established by the Elecsys Free PSA reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.

P000049/S001

4/19/02

180-Day

CardioSEAL® Septal Occlusion System with QwikLoad™

Nitinol Medical Technologies, Inc.

Boston, MA

02210

Approval for the post-approval study protocol for the CardioSEAL® Septal Occlusion System with QwikLoad™.

P000049/S002

4/19/02

180-Day

CardioSEAL® Septal Occlusion System with QwikLoad™

Nitinol Medical Technologies, Inc.

Boston, MA

02210

Approval for the post-approval study protocol for the CardioSEAL® Septal Occlusion System with QwikLoad™.

P000052/S002

4/19/02

180-Day

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the November 2, 2001 approval order for P000052.

P010040/S001

4/18/02

Real-Time

Disintegrator™ Plus Insulin Needle Destruction Device

Safeguard Medical Devices, Inc.

Broadview Heights, OH

44147

Approval for a change in the device to add a port for destruction of lancets. The device, as modified, will be marketed under the trade name Disintegrator™ Plus Needle Destruction Unit and is indicated for home use to destroy 27 to 30 gauge insulin hypodermic needles from 5/16 to ½ inches in length, attached to insulin pens and disposable insulin syringes of 1/3 cc to 1.0 cc volume in size and lancets.

P860019/S181

4/24/02

Maverick™ Monorail™ PTCA Catheter and Maverick™ OTW PTCA Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Alternate manufacturing process to produce balloons for the Maverick™ Monorail™ PTCA Catheter and the Maverick™ OTW PTCA Catheter. The alternate process affects only the method of stretching the balloon tubing prior to molding the balloon.

P900056/S069

4/4/02

Rotablator™ Rotational Angioplasty System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change in the QA Audit process.

P900056/S070

4/11/02

Rotablator™ Rotational Angioplasty System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change in the manufacturing process to eliminate the post-sterilization verification process.

P970035/S035

4/11/02

S7 with Discrete Technology™ Over-the-Wire Coronary Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Change in the process of forming the ring of the stent.

P990020/S008

4/23/02

The AneuRx™ Stent Graft System

Medtronic AVE

Santa Rosa, CA

95407

Change from a manual inspection process to an electronic inspection process for the AneuRx™ Stent Graft System.

P990053/S007

4/18/02

OxiFirst™ Fetal Oxygen Saturation Monitoring System

Tyco Healthcare/ Nellcor Puritan Bennett

Pleasanton, CA

94588

Change in the manufacturing site for the Fetal Sensor Emitter, a component of the OxiFirst™ Fetal Sensor. The sensor emitter will be manufactured at the TYCO facility in Insurgentes, Tijuana, Mexico, where the fetal sensors are manufactured.

P990066/S012

4/3/02

Senographe 2000D Full Field Digital Mammography System

GE Medical Systems

Milwaukee, WI

53188

Addition of a supplier of the High Voltage (HV) tank electronic boards. There will be no labeling changes or design changes to the specifications of the finished device.

P990075/S007

4/23/02

Mentor Spectrum Saline-Filled Breast Implants

Mentor Corporation

Santa Barbara, CA

93111

Change of a supplier of silicone gel materials used in the lubrication of the Spectrum valve channel in the Mentor Spectrum saline-filled breast implants. There will be no changes in any manufacturing processes.

P000025/S003

4/12/02

COMBI 40+ Cochlear Implant System

MED EL Corporation

Durham, NC

27713

Manufacturing process change for the COMBI 40+ Cochlear Implant System.

P000052/S007

4/17/02

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Changes related to the display stop screw and the motor coupling screw in manufacturing the GALILEO™ Intravascular Radiotherapy System.