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PMA Final Decisions Rendered for July 2003

P020047

7/16/03

MULTI-LINK RX and OTW VISION™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95054

Approval for the MULTI-LINK RX and OTW VISION Coronary Stent Systems (CSS).  These devices are indicated for improving coronary luminal diameter in the following:

1) Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm. 

2)  Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm 

3) Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length <25 mm with a reference vessel diameter of 3.0 mm to 4.0 mm.  Outcome (beyond 9 months) for this permanent implant is unknown at present.

P020049

7/29/03

ProCol® Vascular Bioprosthesis

Hancock Jaffe Laboratories, Inc.

Irvine, CA

92614

Approval for the ProCol® Vascular Bioprosthesis.  The device is indicated for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft.

P030027

7/7/03

Ceramic TRANSCEND® Hip Articulation System

Wright Cremascoli Ortho SA

Toulon, France

83089

Approval for the TRANSCEND® Hip Articulation System.  The device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.

P890017/S011

7/15/03

180-Day

Cordis Palmaz Balloon-Expandable Stents

Cordis Corporation

Warren, NJ

07059

Approval for a new manufacturing facility located at Norman Noble, Inc., Highland Heights, Ohio.

P900043/S044

7/2/03

180-Day

Bx Velocity Stent on RaptorRail Stent Delivery System and Bx Velocity Stent with Hepacoat on RaptorRail Stent Delivery System

Cordis Corporation

Warren, NJ

07059

Approval for a new manufacturing facility located at Cordis de Mexico S.A. de C.V., Chihuahua, Mexico.

P920015/S028

7/21/03

Real-Time

Sprint™ Quattro™ Steroid-Eluting Lead Model 6944

Medtronic, Inc.

Minneapolis, MN

55432

Approval for addition of the dexamethasone sodium phosphate (DSP) steroid to the lead tip.

P940015/S008

7/9/03

Real-Time

Synvisc®

(hylan G-F 20)

Genzyme Corporation

Cambridge, MA

02142

Approval for an extension of the shelf life of Synvisc® to 36 months at 30 º C.

P950002/S011

7/8/03

180-Day

BAK™ VISTA™ Interbody Fusion Cage

Centerpulse Spine-Tech, Inc.

Minneapolis, MN

55439

Approval to add the BAK VISTA Interbody Fusion Device, which is manufactured from 65% PEEK Optima and 35% TOHO BESFIGHT C6-UH carbon fiber, to the approved product line for the BAK Interbody Fusion System.  The device will be marketed under the trade name BAK VISTA Interbody Fusion Device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at the L2-S1 spinal levels.  These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).  BAK devices are to be implanted via an open anterior or posterior approach.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.  These patients should be skeletally mature and have had six months of non-operative treatment.

P950019/S013

7/15/03

180-Day

Ray TFC Unite Product Line

Howmedica Osteonics Corporation

Allendale, NH

07401

Approval for new manufacturing facilities for the Ray TFC Unite Product Line.  The facilities are located at Centerpulse Spine-Tech, Minneapolis, Minnesota and Biotest Laboratories, Inc., Minneapolis, Minnesota.

P950022/S017

7/1/03

180-Day

Riata™ Defibrillation Leads, Models 1580, 1581 and 1582

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the addition of a fluoroscopic marker in the helix tip and the addition of new lead lengths and minor modifications to the suture sleeve.  The leads are indicated for permanent sensing and pacing in either the atrium or the ventricle, in combination with a compatible pulse generator.

P960040/S031

7/10/03

180-Day

Vitality™ DS VR Model T135, Vitality™ DS Model T125, and Vitality™ EL Model T127
Implantable Cardioverter Defibrillator (ICD) Systems and the Programmer Software Application Model 2844 Version 3.6

Guidant Corporation

St. Paul, MN

55112

Approval for the Vitality™ DS VR Model T135, Vitality™ DS Model T125, and Vitality™ EL Model T127 Implantable Cardioverter Defibrillator Systems and the Programmer Software Application Model 2844 Version 3.6.  The device, as modified, will be marketed under the trade name Vitality™ DS VR Model T135, Vitality™ DS Model T125, and Vitality™ EL Model T127 Implantable Cardioverter Defibrillator Systems and the Programmer Software Application Model 2844 Version 3.6, and the indication for use is as follows:

Guidant ICDs are intended to provide therapy for the automated treatment of life threatening ventricular arrhythmias. Patient populations who are indicated for a Guidant ICD include  1)  Those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or  2) Patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction of ≤30% (as defined in Appendix E ).

P960058/S030

7/7/03

180-Day

HiResolution™ Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the repackaged ICS (Implantable Cochlear Stimulator), referred to as HiRes™ 90K, and its associated surgical tools.  The device, as modified, will be marketed under the trade name HiResolution™ Bionic Ear System and is indicated for adults and the pediatric population aged 12-months through 17 years, 11-months of age.

P970008/S023

7/7/03

180-Day

Urologix Targis™ System for the Treatment of BPH

Urologix, Inc.

Minneapolis, MN

55447

Approval for 1) the RTU Plus™, a modified version of the Rectal Thermosensing Unit (RTU), and  2) labeling changes.  The RTU Plus™ includes a disposable balloon and reusable handle, and will be available as an alternative to the existing single use RTU.

D970012/S015

7/2/03

180-Day

AMS 700™ Series Inflatable Penile Prosthesis Product Line: 700CXR™

American Medical System, Inc.

Minnetonka, MN

55343

Approval for the addition of a modified version of the AMS 700CXM™ penile prosthesis to the AMS 700™ Series Inflatable Penile Prosthesis Product Line.  The device, as modified, will be marketed under the trade name AMS 700CXR™, and is indicated for the treatment of chronic, organic, male erectile dysfunction (impotence).

D970012/S017

7/15/03

Real-Time

AMS 700™ Series Inflatable Penile Prosthesis Product Line

American Medical System, Inc.

Minnetonka, MN

55343

Approval for the addition of a tubing plug to the accessory kit for the AMS 700™ Series Inflatable Penile Prosthesis Product Line.

P970020/S043

7/22/03

180-Day

ACS MULTI-LINK DUET™ Coronary Stent System

Guidant Corporation

Temecula, CA

92591

Approval to change the post-approval requirement period from 5 to 4 years and to update the labeling with clinical data from 4 year follow-up.

P970020/S044

7/16/03

180-Day

MULTI-LINK RX ZETA™ Coronary Stent System

Guidant Corporation

Temecula, CA

92591

Approval for a modification to the Delivery System for the MULTI-LINK RX ZETA™ Coronary Stent System.

P970021/S008

7/14/03

180-Day

GYNECARE THERMACHOICE™ II Uterine Balloon Therapy System

Ethicon, Inc.

Somerville, NJ

08876

Approval for modified labeling for the THERMACHOICE II.

P970043/S013

7/16/03

Real-Time

LADARVision® 4000 Excimer Laser System

Alcon Laboratories, Inc.

Orlando, FL

32826

Approval for an expansion of ± 0.75 D for the allowable target offset parameter range for the wavefront-guided myopic LASIK indication.  The device, as modified, will be marketed under the trade name LADARVision® 4000 Excimer Laser System and is indicated for the reduction or elimination of myopia up to -7.00 D with less than -0.50 D of astigmatism at the spectacle plane.

P980016/S035

7/30/03

Real-Time

Marquis VR ICD (Model 7230)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the use of the Model 2490E CareLink Monitor and Model 2491 DDMA Software with the Marquis VR ICD.

P980023/S013

7/29/03

180-Day

Kentrox RV 65, Kentrox RV 75, Kainox SL 65/13, Kainox SL 65/18

Biotronik, Inc.

Lake Oswego, OR

97035

Approval of the post-approval study for the device.

P980049/S009

7/2/03

Real-Time

Alto 2 Models DR 624 and VR 625 ICDs, Orchestra Application Software (Elaview 1.06 UG2), and separately packaged IS-1 and DF-1 port plugs

ELA Medical, Inc.

Plymouth, MN

55441

Approval for down-sized versions of the Alto Models DR 614 and VR 615 implantable cardioverter defibrillatos (ICDs), modifications to the Orchestra Application Software, and the addition of separately packaged IS-1 and DF-1 port plugs.  The ICD devices, as modified, will be marketed under the trade names Alto DR Model 624 ICD and Alto VR Model 625, and are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations:  (1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; (2) recurrent, poorly tolerated, sustained ventricular tachycardia (VT).  Note:  The clinical outcome for hemodynamically stable VT patients is not fully known.  Safety and effectiveness studies have not been conducted.   The modified application software will be marketed under the trade name Orchestra Application Software (Elaview 1.06 UG2).

P990009/S014

7/10/03

180-Day

FloSeal® NT Hemostatic Matrix

Baxter Healthcare Corporation

Fremont, CA

94555

Approval for an alternate trade name for the approved kit configuration that does not contain a thrombin component.  The device, as modified, will be marketed under the trade name FloSeal® NT Hemostatic Matrix and is indicated for use in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

P990034/S004

7/21/03

Special

Medtronic® IsoMed® Model 8472 Fixed Rate Infusion System

Medtronic, Inc.

Minneapolis, MN

55342

Approval for labeling changes to the Models 8553 and 8555 IsoMed Refill Kit Instructions for Use and the Technical Manual.

P990074/S015

7/22/03

180-Day

McGhan Saline-Filled Breast Implants

Inamed Corporation

Santa Barbara, CA

93111

Approval for a manufacturing site located at Inamed Corporation, Wicklow, Ireland.

P000006/S003

7/14/03

180-Day

Titan™ Inflatable Penile Prosthesis

Mentor Corporation

Santa Barbara, CA

93111

Approval for marketing claims regarding water absorption by the Titan™ Inflatable Penile Prosthesis.

P000018/S029

7/18/03

180-Day

Novoste™ Beta-Cath™ 3.5F System

Novoste Corporation

Norcross, GA

30093

Approval for the

β-Rail™ 3.5F XL Delivery Catheter and Enhanced

β -Rail™ 3.5F Delivery Catheter.

P000025/S010

7/25/03

Real-Time

MED-EL COMBI 40+ Cochlear Implant System, TeleMic™ and Microphone Test Device™

MED-EL Corporation

Durham, NC

27713

Approval for the MED-EL COMBI 40+ Cochlear Implant System to include the following accessories for the TEMPO+ Speech Processor: TeleMic™ and Microphone Test Device (MTD™).  The TeleMic™ is indicated for the COMBI 40+ Cochlear Implant user who desires either a direct connection to a telephone or an induction loop or additional amplification of the TEMPO+ Speech Processor internal microphone.  The MTD™ is indicated for individuals who wish to qualitatively monitor the microphone signal of the TEMPO+ speech processor.

P000025/S011

7/22/03

180-Day

MED-EL COMBI 40+ Cochlear Implant System

MED-EL Corporation

Durham, NC

27713

Approval for vertical integration of the cochlear implant laser welding process at the manufacturing site located at MED-EL Medical Electronics, Innsbruck, Austria.

P000028/S003

7/2/03

180-Day

Affinity Anterior Cervical Cage System

Medtronic Sofamor Danek

Memphis, TN

18132

Approval for additional manufacturing facility to perform packaging for terminal sterilization.  The facility is located at Medtronic Sofamor Danek, Warsaw, Indiana.  Also, approval for an additional sterilization facility located at IBA SteriGenics, Westerville, Ohio and an additional testing facility located ad NaMSA, Northwood, Ohio.

P000052/S019

7/24/03

Special

GALILEO® and GALILEO® III Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Approval of the following changes to the labeling:  1) Adding a warning statement alerting users to the potential for a radiation overdose if an interrupted treatment is not resumed appropriately.  2) Modifying the Emergency Response procedures to assist users to retract the active wire in the most expeditious manner while maintaining safety of the patient and the radiation personnel involved in case of an emergency.

P010012/S011

7/10/03

180-Day

Programmer Software Application Model 2844 Version 3.6

Guidant Corporation

St. Paul, MN

55112

Approval for the Programmer Software Application Model 2844 Version 3.6

P010012/S012

7/2/03

Real-Time

Model 2848 CONTAK CD Programmer Software Application (version 3.2)

Guidant Corporation

St. Paul, MN

55112

Approval for the Model 2848 CONTAK CD Programmer Software Application, version 3.2.

P010018/S004

7/31/03

180-Day

ViewPoint CK System

Refractec, Inc.

Irvine, CA

92618

Approval for an alternate manufacturing facility for the sub-assembly of the RCS-300 console.  The manufacturing facility is located at Refractec, Inc., Irvine, California.

P010031/S005

7/21/03

180-Day

InSync II Marquis™ Model 7289 with Model 9989 Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the InSync II Marquis™ Model 7289 with Model 9989 Application Software.  The system as modified, will be marketed under the trade name InSync II Marquis™ and is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction less than or equal to 35 percent and a QRS duration greater than or equal to 130 ms.

P020014/S002

7/1/03

Real-Time

Conceptus Essure™ System for Permanent Birth Control

Conceptus, Inc.

San Carlos, CA

94070

Approval for a change to the anchoring of the proximal longitudinal polyethylene terepthalate (PET) fibers on the implant.

P020014/S004

7/17/03

Real-Time

Conceptus Essure™ System for Permanent Birth Control

Conceptus, Inc.

San Carlos, CA

94070

Approval for new expiration dates for the gamma catheter (with packaging process improvements) and the coil catheter (with packaging process improvements.)

N17600/S020

7/11/03

Avitene® Microfibrillar Collagen Hemostat (MCH)  Flour and Avitene® UltraFoam® Cast Microfibrillar Collagen Hemostat (MCH) Sponge

Davol, Inc.

Cranston, R.I.

02920

Change the procedure for recording temperatures during the dry heat sterilization process of the Avitene products.

P800002/S013

7/11/03

Avitene® Microfibrillar Collagen Hemostat (MCH) Non-Woven Web

Davol, Inc.

Cranston, R.I.

02920

Change the procedure for recording temperatures during the dry heat sterilization process of the Avitene products.

P840039/S052

7/23/03

PMMA IOL’s: Models EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV and L122UV

Bausch & Lomb

San Dimas, CA

91773

Change in the frequency of the bioburden testing.

P860019/S196

7/25/03

PTCA Catheters

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the manufacturing coating process for all currently marketed PTCA catheters and coronary stent (balloon expandable) delivery systems.

P880090/S019

7/23/03

PMMA IOL’s: Models EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV and L122UV

Bausch & Lomb

San Dimas, CA

91773

Change in the frequency of the bioburden testing.

P900056/S077

7/8/03

Rotablator Rotational Angioplasty System

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process of the Rotablator Rotational Angioplasty System which involves the elimination of the QA Audit for the Catheter Burr subassembly.

P900060/S026

7/25/03

CarboMedics Prosthetic Heart Valve (CPHV)

CarboMedics, Inc.

Austin, TX

78752

Change in the manufacturing process of the paper used in the manufacture of the vent covers included in the packaging of the CarboMedics Prosthetic Heart  valve  (CPHV).

P910061/S010

7/23/03

SoFlex IOL’s Models LI61U & LI51U

Bausch & Lomb

San Dimas, CA

91773

Change in the frequency of the bioburden testing.

P960004/S022

7/2/03

ThinLine™ II Sterox/

FINELINE™ II Sterox Endocardial Pacing Leads

Guidant Corporation

St. Paul, MN

55112

Addition of a biocompatible adhesive to the lead which will enhance the ability to maintain the position of the drug-eluting collar at its designed location.

P980001/S043

7/25/03

NIR® Premounted Stent Delivery Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the manufacturing coating process for all currently marketed PTCA catheters and coronary stent (balloon expandable) delivery systems.

P990009/S015

7/3/03

FloSeal® Matrix Hemostatic Sealant

Baxter Healthcare Corporation

Fremont, CA

94555

Change from a manual packaging process to a semi-automated process.

P990037/S020

7/11/03

Duett™ Pro Model 1010 and Diagnostic Duett™ Pro Model 2210

Vascular Solutions, Inc.

Minneapolis, MN

55369

Change in the tensile test method, which tests the functionality of the catheter using a method that aligns it with the required specification.

P000014/S006

7/9/03

Vitros Immunodiagnostic Products anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Introduction of an additional raw materials supplier for uncoated microwells that are used for the manufacture of the coated microwells by Ortho-Clinical Diagnostic for the anti-HBs Reagent Pack.

P000049/S009

7/3/03

CardioSEAL® Septal Occlusion System with Qwik Load

NMT Medical

Boston, MA

02210

Change in the manufacturing process which involves a change to bacterial endotoxin assay sample size.

P020009/S009

7/25/03

Express/Express^2™ Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Change to the manufacturing coating process for all currently marketed PTCA catheters and coronary stent (balloon expandable) delivery systems.