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PMA Final Decisions Rendered for October 1998

P960006

10/2/98

SWEET TIP® Rx Models 4143, 4144, 4145, 4243, 4244, and 4245 Steroid-Eluting, Positive-Fixation, Porous Tip, Pacing Leads

Guidant Corporation

St. Paul, MN

55112-5798

Approval for the SWEET TIP® Rx Models 4143, 4144, 4145, 4243, 4244, and 4245 steroid-eluting, positive-fixation, porous tip, pacing leads. These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.

P960014

10/5/98

Magellan-C PTCA Catheter

Global Therapeutics, Inc.

Broomfield, CO

80020

Indicated for balloon dilatation of the stenotic portion of a coronary or bypass graft stenosis for the purpose of improving myocardial perfusion.

P980016

10/9/98

Medtronic® Model 7271 GEM^TM DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9960 (GEM^TM DR) Application Software, Medtronic® Model 6940 CapSureFix® Lead and Model 9466 Patient Magnet

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® Model 7271 GEM^TM DR Dual Chamber Implantable Cardioverter Defibrillator System with Mdoel 9960 (GEM^TM DR) Application Software, Medtronic® Model 6940 CapSureFix® Lead and Model 9466 Patient Magnet. This system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (Note: the clinical outcome for hemodynamically stable VT patients is not fully known. Safety and effectiveness studies have not been conducted.)

P980023

10/27/98

Phylax Implantable Cardioverter Defibrillator (ICD) System

Biotronik, Inc.

Lake Oswego, OR

97035-5369

Approval for the Phylax Implantable Cardioverter Defibrillator (ICD) System: a) ICD Pulse Generator - Phylax XM ICD, model number 121491; Phylax XM Active Housing ICD, model number 121492; Phylax XM Replacement ICD, model number 121162 and mycroPhylax ICD, model number 121493; b) ICD Lead - SPS 75 Lead System, model number 120398; SL-ICD Lead Systems (SL-ICD 75/13, model number 120395, SL-ICD 75/16, model number 120396, SL-ICD 75/18, model number 120397, SL-ICD 100/13, model number 116414, SL-ICD 100/16, model number 118375, SL-ICD118375, SL-ICD 100/18, model number 119077); Kainox SL Lead Systems (Kainox SL 75/13, model number 124219, Kainox SL 75/16, model number 124218, Kainox SL 75/18, model number 124217, Kainox SL 100/13, model number 124238, Kainox SL 100/16, model number 124239, Kainox SL 100/18, model number 124240); Kainox RV 75 Lead System, model number 124005; and (c) Programming and Monitoring System - TMS 1000 Tachyarrhythmia Monitoring System, and Software Module SWM 1000 F00I01. This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmia; or recurrent poorly tolerated sustained ventricular tachycardia (VT). Note: The clinical outcome for hemodynamically stable VT patients is not fully know. Safety and effectiveness studies for this indication have not been conducted.

N18466/S023*

10/21/98

ORTHOSET® Bone Cement

Wright Medical Technology, Inc.

Arlington, TN

38002

Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.

P790007/S015

10/30/98

HANCOCK® Modified Orifice (MO) Porcine Bioprosthesis, Model 250

Medtronic Cardiac Surgery

Minneapolis, MN

55432-3576

Approval for exemption from annual reporting on the post-market study for this device.

P790020/S059*

10/27/98

Permaflex Naturals (Surfilcon A) Hydrophilic Contact Lenses

CooperVision

Scottsville, NY

14546

Approval for a ten year expiration date for the Permaflex Naturals (Surfilcon A) Hydrophilic contact lenses.

P810020/S005*

10/15/98

Osteopal® Radiopaque Bone Cement

Smith & Nephew Richards, Inc.

Memphis, TN

38116

Approval for changes to package insert.

P810046/S192

10/16/98

ACS RX SOLARIS^TM Coronary Dilatation Catheter

Guidant Corporation

Santa Clara, CA

95052

Approval for the ACS RX SOLARIS^TM Coronary Dilatation Catheter and a modification to the Instructions for Use for ACS PTCA Catheters. The ACS RX SOLARIS^TM Coronary Dilatation Catheter is indicated for balloon dilatation of: 1) the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.

P830045/S061*

10/21/98

APS III Model 3500 Programmer Software Rev. D (version 1.04)

St. Jude Medical

Sylmar, Ca

91392

Approval for the APS III Model 3500 Programmer Software Revision D (version 1.04).

P830061/S029

10/9/98

Medtronic CapSure® SP Model 4523 Pacing Lead

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for removing the platinum sputtering from the conductor coil of the device.

P850089/S040*

10/29/98

Medtronic® CapSure SP Novus Steroid Eluting, Transvenous Pacing Leads Models 5092 and 5592

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for distribution under a new trade name. The devices will be marketed under the trade name Vitatron® Excellence SS+ Models IML 49B and IML 49JB and indicated for use with pulse generators as part of a caridac pacing system to provide chronic pacing and sensing of the ventricle.

P860019/S144

10/1/98

SCIMED® MAXXUM^TM Percutaneous Transluminial Coronary Angioplasty (PTCA) Catheter

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for the SCIMED® MAXXUM^TM PTCA Catheter. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

P880086/S053*

10/21/98

APS III Model 3500 Programmer Software Rev. D (version 1.04)

St. Jude Medical

Sylmar, CA

91392

Approval for the APS III Model 3500 Programmer Software Revision D (version 1.04).

P900052/S005

10/20/98

PORT-A-CATH® II Epidural Low Profile^TM Implantable Access System

SIMS Medical Systems

St. Paul, MN

55112

Approval for 1) The following design modifications to the current, legally marketed PORT-A-CATH® II: a smaller (25.4mm. based diameter, a 12.7mm. height, and a 8.9mm. septum diameter), lighter weight (5.0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(SS) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the CATH-SHIELD catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.

P900061/S035

10/5/98

Medtronic® Model 7227Cx GEM^TM Implantable Cardioverter

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for the Medtronic® Model 7227Cx GEM^TM Implantable Cardioverter Defibrillator with Model 9962 Software and the Model 9466 Patient Magnet.

P900070/S024*

10/29/98

Tempo^TM Pulse Generator Models 1102, 1902, 2102, and 2902

Pacesetter, Inc.

Sylmar, CA

91342-9221

Approval for an extension of product shelf life from 12 months to 18 months.

P910023/S033

10/21/98

Ventritex® Contour® MD/Angstrom^TM MD Implantable Cardioverter/

Defibrillator System

St. Jude Medical, Inc.

Sunnyvale, CA

94086-6527

Approval of the Ventritex® Contour® MD Models V-175, V-175B, V-175C, V- 175D and V-175AC and the Angstrom^TM MD Models V-190F and V-190HV3.

P910023/S034

10/22/98

Contour® II/Angstrom^TM II ICD Systems

St. Jude Medical

Sunnyvale, CA

94086-6527

Approval for a manufacturing site located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.

P910061/S004*

10/2/98

SOFLEX UV-Absorbing Silicone Posterior Chamber Intraocular Lenses (IOLs)

Bausch & Lomb Surgical

Claremont, CA

91711

Approval for a change in the raw material specifications for SOFLEX IOLs.

P910066/S012*

10/16/98

OrthoLogic 1000-SC Bone Growth Stimulator

OrthoLogic Corporation

Tempe, AZ

85281

Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

P910077/S024*

10/26/98

Model 6998 IS-1 Lead Port Plug

Guidant Corporation

St. Paul, MN

55112-5798

Approval for the model 6988 IS-1 Lead Port Plug.

P920023/S006*

10/2/98

UroLume® Endoprosthesis- Recurrent Bulbar Urethral Strictures Application and Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH) Application

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for the addition of a warning to the device labeling to reflect an unexpected adverse event.

P930012/S013

10/22/98

LaCrosse, Champion, Champion NC, Wrap, and Wrap NC PTCA Catheters

United States Surgical Corporation

Norwalk, CT

06856

Approval for a sterilization site located at Griffith Micro Science, Inc., (Chamber #8 only), 4900 S. Gifford Ave., Los Angeles, CA 90058.

P930014/S005

10/9/98

AcrySof® Acrylic Posterior Chamber Intraocular Lens (IOL)

Alcon Laboratories, Inc.

Fort Worth, TX

76134

Approval for changes to the labeling.

P930034/S008

10/8/98

SVS Apex and SVS Apex Plus Excimer Laser Workstations

Summit Technology, Inc.

Waltham, MA

02154

Approval for the central island pretreatment software option.

P940031/S016*

10/2/98

MERIDIAN^TM and DISCOVERY^TM Pacemaker Systems

Guidant Corporation

Cardiac Pacemakers (CPI)

St. Paul, MN

55112-5798

Approval for changes to the Model 2890 Software Application from Version 1.20 to Version 2.12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the DISCOVERY^TM/ MERIDIAN^TM pacemakers which provides consistency with the VIGOR pacemakers.

P950014/S016

10/14/98

Prostatron®

EDAP Technomed, Inc.

Burlington, MA

01803

Approval for modifications to the Prostatron's® labeling which summarize the results of the postapproval study.

P950015/S001

10/6/98

The Heart Laser^TM CO₂ TMR System

PLC Medical Systems, Inc.

Franklin, MA

02038

Approval for the post approval clinical study to be conducted as a condition of approval.

P950019/S005*

10/29/98

Ray Threaded Fusion Cage (TFC)(with instrumentation)

United States Surgical Corporation

Norwalk, CT

06856

Approval for modified instrument inserts.

P950022/S003

10/22/98

SPL Tripolar, Tined, Transvenous Defibrillation Leads, Models SP01, SP02, SP03, and SP04

St. Jude Medical

Sunnyvale, CA

94086-6527

Approval for a manufacturing site located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.

P950029/S002*

10/9/98

Model CPR1D Programmer Head

ELA Medical

Plymouth, MN

55441

Approval for the new Model CPR1D Programmer Head.

P970008/S009*

10/29/98

Urologix Targis^TM System

Urologix, Inc.

Minneapolis, MN

55447

Approval for minor changes in the design and labeling of the Rectal Thermosensing Unit.

P970012/S006*

10/15/98

Medtronic.Vision Model 9952 Series 2.1 and 9952A Series 2.1 Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for software changes to the Medtronic.Vision Model 9952 Series 2.1 and 9952A Series 2.1 Software.

P970058/S001*

10/21/98

ImageChecker M1000

R2 Technology, Inc.

Los Altos, CA

94022

Approval for design changes that relocate the SCSI, support a new paper printer, correct several minor bugs and add minor operational enhancements.

N18286/S010**

10/14/98

Gelfoam® Sterile Sponge

Pharmacia & Upjohn

Kalamazoo, MI

The 30-day Notice request the addition of a new packaging machine (Doyen) to package/seal the outer envelope (primary sterile barrier) of the Gelfoam® sterile sponge. The addition of the new packaging machine resulted in other change that included a new paper vendor and a change in the application of the adhesive pattern on the package. The label copy will be printed on line and no longer supplied by the paper vendor; and the smallest Gelfoam® package size, 12-7 (3"x71/2") was changed to 4"x71/2" due to limitations of the Doyen packaging machine. As a result of this packaging size change, the sterilization process was validated successfully. A UV decontamination procedure was also incorporated into the Standard Operating Procedure for Container Closure Integrity testing to minimize the risk of the false-positive results during sterility testing. The added packaging equipment will be used as the primary packaging line, while the current packaging equipment (Circle) will be used as an alternate.

P830045/S060**

10/15/98

St. Jude Medical

Sylmar, CA 91342

The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

P860057/S009**

10/26/98

Carpentier-Edwards® PERIMOUNT® Pericardial Valve Models 2700 and 2800

Baxter Healthcare Corporation

Santa Ana, CA

97221-1150

The 30-day Notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprotheses.

P870056/S010**

10/26/98

Carpentier-Edwards® Bioprosthesis Models 2625 and 6625

Baxter Healthcare Corporation

Santa Ana, CA

97221-1150

The 30-day Notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprotheses.

P870077/S008**

10/26/98

Carpentier-Edwards® Duraflex^TM Bioprosthesis Models 6625LP and 6625 LP-ESR

Baxter Healthcare Corporation

Santa Ana, CA

97221-1150

The 30-day Notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprotheses.

P880006/S028**

10/15/98

St. Jude Medical

Sylmar, CA 91342

The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

P880086/S052**

10/15/98

St. Jude Medical

Sylmar, CA 91342

The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

P900070/S023**

10/15/98

St. Jude Medical

Sylmar, CA 91342

The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

P960013/S004**

10/15/98

St. Jude Medical

Sylmar, CA 91342

The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

P960030/S003**

10/15/98

St. Jude Medical

Sylmar, CA 91342

The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

P960030/S004**

10/8/98

Passive Plus® Endocardial Pacing Leads

St. Jude Medical

Sylmar, CA

91342

The 30-day Notice requested that FDA review a change in material from ETR and MDX silicone rubber to liquid silicone rubber, and a change in the manufacturing process, from transfer molding to liquid injection molding, using an approved vendor. These changes apply to the fins, tines, and suture sleeve components of the Passive Plus® Endocardial Pacing Leads.

P970003/S011**

10/16/98

NeuroCybernetic Prosthesis System

The 30-day Notice requested that a welding process be added to the firms' internal manufacturing capabilities. This process is equivalent to the welding process already performed by Cyberonics' subcontractors. The process is being brought in-house in order to simplify the manufacturing process, improve control of product flow, and improve product availability.

P970031/S007**
10/30/98

Medtronic FREESTYLE Aortic Bioprosthesis

Medtronic Heart Valves Division

Santa Ana, CA

92705

The 30-day Notice requested a change in the method in which a raw material (AOA compound) is synthesized. This will result in the raw material being received in a more purified form. The quality control test performed in incoming inspection will change from the Gravimetric test method to the Ninhydrin test method.