4/27/99

PRO-Trac II™ Tacrolimus ELISA Kit

DiaSorin, Inc.

Columbia, MD

21046

Approval for PRO-Trac™ II Tacrolimus ELISA Kit. This device indicated for the quantitative determination of tacrolimus (Prograf® FK506) and some metabolites in EDTA or heparinized human whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.

4/16/99

TransScan T-Scan 2000

TransScan Medical, Inc.

Ramsey, NJ

07446

Approval for the TransScan T-Scan 2000. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding within ACR BI-RADS™ categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.

4/9/99

KeraVision Intacs™

KeraVision, Inc.

Fremont, CA

94538-7353

This device is indicated for the reduction or elimination of mild myopia (-1.00 to

–3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less.

4/28/99

Home Access® Hepatitis C Check^sm and Hepatitis C Check^sm Express

Home Access Health Corporation

Hoffman Estates, IL

60195-5200

Approval for the Home Access® Hepatitis C Check^sm and Hepatitis C Check^sm Express. This device is indicated for home use for collection of a dried blood spot specimen by finger-stick, and is indicated for anonymous testing for antibody to hepatitis C virus (HCV) in adults, eighteen years or older, who may have been exposed to HCV through transfusion or organ transplant before 1992, who may have injected non-prescription drugs, or who were exposed to infected needles or had sexual contacts with HCV infected individuals.

4/26/99

GELFOAM® Sterile Powder

Pharmacia & Upjohn Company

Kalamazoo, MI

49001-0199

Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder.

4/16/99

St. Jude Medical® Mechanical Heart Valve/SJM® Master Series Mechanical Heart Valve, Mitral Sizes 35mm and 37mm/SJM® Master Series Mechanical Heart Valve with Silzone™ Coating, Mitral Sizes 35mm and 37mm

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM® Master Series Mechanical Heart Valve product line (SJM™ Master Series with Polyester Cuff, model number MJ-501, and SJM® Master Series with Silzone™ coating, Polyester Cuff, model number MS-601).

4/14/99

ACS RX Solaris™ Coronary Dilatation Catheter

Guidant Corporation

Santa Clara, CA

95052

Approval for additional balloon sizes and an additional indication for use for the ACS RX Solaris™ Coronary Dilatation Catheter. The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. c) Balloon dilatation of the ACS MULTI-LINK DUET™ stent after implantation.

4/21/99

Model 3510 Programmer with Model 3303 version 1.02 Software

St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.

4/7/99

SpF-2T, SpF-4T and SpF-XL IIb Implantable Spinal Fusion Stimulator

Electro Biology, Inc.

Parsippany, NJ

07054-1079

Approval for labeling changes stating the device was MR Safe.

4/5/99

Life Pulse High Frequency Ventilator

Bunnell, Inc.

Salt Lake City, UT

84115

Approval for extending the duration of use for the breathing circuit.

4/15/99

Frequency™ 55, CooperFlex™, Envoy™, Onevue™, Sterling 55 and Clear Comfort™ (methafilcon A) Spherical and Frequency™ (methafilcon A) Toric Contact Lenses for Extended Wear (Clear and Handling Tint with In-Monomer Tinting Process, Cast-molded)

COOPERVISION, Inc.

Scottsville, NY

14546

Approval for an alternate tinting process, In-Monomer-Tinting Process.

4/8/99

SCIMED® NC MAXXUM™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for the SCIMED NC MAXXUM™ PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, - 5.0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameters of 2.5-4.0mm in 1/4mm increments and 4.5mm – 5.0mm) in 1/2mm increments. The NC MAXXUM™ PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for the purpose of improving myocardial perfusion. The NC MAXUUM™ PTCA Catheter (balloon models 2.5-4.0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.

4/5/99

ADANTE™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for the ADANTE™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (20 mm length with balloon diameters of 1.5 mm, and 2.0 - 4.0 mm in 1/4 mm increments, and 30 and 40 mm lengths with balloon diameters of 2.0 – 4.0 mm in 1/4 mm increments). The ADANTE™ PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocaridal perfusion. The ADANTE™ PTCA Catheter (balloon models 2.5 - 4.0 mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.

4/9/99

SCIMED® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for minor labeling revisions to the Instructions for Use manual for the Scimed® PTCA Catheters.

4/30/99

Lithostar Multiline Lithotripter

Siemens Medical, Systems, Inc.

Iselin, NJ 08830

Approval for a manufacturing site located at Siemens AG, Roentgenstrasse 19- 21, Kemnath, Germany. Final assembly and system testing of the Lithostar Multiline will be performed at this facility.

4/12/99

Aortic Valvuloplasty Catheter

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for a manufacturing site located at SCIMED Life Systems, Inc., Two SCIMED Place, Maple Grove, MN 55311.

4/21/99

Model 3510 Programmer with Model 3303 version 1.02 Software

St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.

4/15/99

PALMAZ-SCHATZ™ MiniCrown Balloon-Expandable Stent with Dynasty™ Over the Wire Delivery System

Cordis Corporation

Warren, NJ

07059

Approval for the PALMAZ-SCHATZ™ MiniCrown Balloon Expandable Stent with Dynasty™ Over the Wire Delivery System

(11mm and 15mm stent lengths with 2.25, 2.50, 2.75, 3.00, and 3.25mm balloon diameters). The device is indicated for improving coronary luminal diameter in the following: Treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions

(£ 25mm) with a reference vessel diameters in the range of 2.25 to 3.25mm. Long term outcome (beyond

1 month) for this permanent implant is unknown at present.

4/21/99

PORT-A-CATH® Epidural Implantable Access System

SIMS Medical Systems

St. Paul, MN

55112

Approval for a change in the postapproval protocol to allow the use of the Low Profile system which was approved on 10/28/98.

4/15/99

Medtronic® Model 7227 Cx GEM™ Implantable Cardioverter Defibrillator

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval to implement a new test Method and specification for screening the Medtronic® Model 7227 Cx GEM™ Implantable Defibrillators for premature battery depletion.

4/19/99

Cadence® Tiered Therapy Defibrillator System

St. Jude Medical, Inc.

Sunnyvale, CA

94086-6527

Approval for an extension of the shelf life from 9 months to 18 months for the Contour® MD Model V-175 and the Contour® II Model V-185 Implantable Cardioverter Defibrillators.

4/19/99

Cadence® Tiered Therapy Defibrillator System

St. Jude Medical, Inc.

Sunnyvale, CA

94086-6527

Approval for a labeling change to reflect compatibility of the Contour II/MD, Angstrom II/MD, and Profile II/MD implantable defibrillators with cellular phones.

4/20/99

OrthoLogic 1000 Bone Growth Stimulator

OrthoLogic Corporation

Tempe, AZ

85281

Approval for updating the Patient Registry Data Sheet.

4/13/99

UroLume® Endoprosthesis

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for a windowless version of the UroLume® Endoprosthesis delivery tool.

4/14/99

EPT-1000 Cardiac Ablation System

Boston Scientific/

EP Technologies

San Jose, CA

95134

Approval for an alternate contract sterilizer and a change of biological indicator.

4/27/99

Angio-Seal™ Hemostatic Puncture Closure Device

Kendall Company

Bothell, WA

98021

Approval for a modification to the collagen sponge shape.

4/26/99

Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) System

B.Braun Medical, Inc.

Bethlehem, PA

18018

Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter.

4/5/99

Celsius™ Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode)

Cordis Webster, Inc.

Diamond Bar, CA

91765

Approval for the 7 Fr and 8 Fr catheters incorporating a 5mm tip electrode. The device, as modified, will be marketed under the trade name Celsius™ Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) and is indicated for interruption of accessory AV conduction pathways assocated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. In addition to these indications, the 7 Fr catheter is also indicated for persistent junctional reciprocating tachycardia, Mahaim fibers, and pediatric patients (age 4 years or older).

4/27/99

The Heart Laser CO₂ TMR System

PLC Medical Systems, Inc.

Franklin, MA

02038

Approval for changes to the labeling.

4/9/99

SWEET PICOTIP™ Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads

Guidant Corporation

St. Paul, MN

55112-5798

Approval for several new lead models: the SWEET PICOTIP™ Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 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.

4/9/99

Locator™ Steerable Stylet Model 4036

St. Jude Medical

Sylmar, CA

91342

Approval for changes to the User's Manual and package label for the Locator™ Steerable Stylet Model 4036.

4/1/99

Reliance® Urinary Control Insert and Sizing Device

UroMed Corporation

Norwood, MA

02062

Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device.

4/9/99

Techstar® XL 6 French and Prostar® XL 8 and 10 French Percutaneous Vascular Surgical (PVS) Systems

Perclose, Inc.

Menlo Park, CA

94025

Approval for a modification to the suture lumen.

4/21/99

ADCON®-L Adhesion Control in a Barrier Gel

Gliatech, Inc.

Cleveland, OH

44122

Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syringe configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.

4/15/99

Medtronic® Interstim® System for Urinary Control

Medtronic, Inc.

Minneapolis, MN

55440-9087

Approval for the Medtronic® Interstim® System for Urinary Control. This device is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments.

4/29/99

Hologic Sahara Clinical Bone Sonometer

Hologic, Inc.

Bedford, MA

01730

Approval for a change in the manufacturing site to 35 Crosby Dr., Bedford, MA 01730.

4/27/99

Micro Stent® II and GFX™ Over-the-Wire Coronary Stent Systems

Arterial Vascular Engineering, Inc.

Santa Rosa, CA

95403

Approval for the 5-year post-approval study protocol for the Micro Stent® II and GFX™ Over-the-Wire Coronary Stent Systems.

4/8/99

Medtronic AVE GFX® 2 Over-The-Wire Coronary Stent System

Arterial Vascular Engineering, Inc.

Santa Rosa, CA

95403

Approval for the Medtronic AVE GFX® 2 Over-The-Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm. Long term outcome (beyond six months) for this permanent implant is unknown at present.

4/23/99

Achilles Express

Lunar Corporation

Madison, WI

53713

Approval for a design change that was primarily to replace the open water bath with water enclosed in silicone membranes. The device, as modified, will be marketed under the trade name Achilles Express and is indicated for: The Achilles Express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by x-ray absorptiometry at the spine or hip.

4/21/99

SCIMED® RADIUS™ Coronary Stent with Delivery System

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Proposal for 5 year post-approval study protocol.

4/15/99

Medtronic® Model 7273 GEM™ II Dual Chamber Implantable Cardioverter Defibrillator

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for screening the Medtronic® Model 7271 GEM™ II Dual Chamber Implantable Cardioverter Defibrillators for premature battery depletion.

4/19/99

Phylax Implantable Cardioverter Defibrillator (ICD) System

Biotronik, Inc.

Lake Oswego, OR

97035-5369

Approval for modifications to the programmer software used with Biotronik's MycroPhylax and Phylax XM ICD's.

4/1/99

Medtronic.Vision Software Models 9953/9953A – Series 1.3

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for the Medtronic.Vision Software Models 9953 and 9953A (Series 1.3) for use with the Medtronic Model 9790 programmers to program the Medtronic Kappa 700 series pacemakers. The device, as modified, will be marketed under the trade name Medtronic.Vision Software Models 9953/9953A and is indicated for use with the Medtronic Kappa 700 series pacemakers to allow electrophysiology stimulation (EPS) functions.

APPLICATION NUMBER & LTR DATE

DEVICE NAME

COMPANY NAME

COMMENTS

P860057/S010**

4/13/99

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

Baxter Healthcare Corporation

Santa Ana, CA

92711-1150

The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly.

P870056/S011**

4/13/99

Carpentier-Edwards® Bioprosthesis, Model 2625 and 6625

Baxter Healthcare Corporation

Santa Ana, CA

92711-1150

The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly.

P870077/S009**

4/13/99

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

Baxter Healthcare Corporation

Santa Ana, CA

92711-1150

The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly.

P950032/S009**

4/19/99

Apligraf™

Organogenesis, Inc.

Canton, MA

02021

The 30-day Notice requested a manufacturing process change for Apligraf™ . The requested change will place into the manufacturing process 3 additional production-scale incubators manufactured by Lunaire Corporation (model #CI0641W-6SPL).

P970003/S019**

4/5/99

NeuroCybernetic Prosthesis System

Cyberonics

Webster, TX

77598

The 30-Day Notice requested relocation of the Seam Welding Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.

P970003/S020**

4/5/99

NeuroCybernetic Prosthesis System

Cyberonics

Webster, TX

77598

The 30-Day Notice requested relocation of the Feed Through Welding Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.

P970003/S021**

4/5/99

NeuroCybernetic Prosthesis System

Cyberonics

Webster, TX

77598

The 30-Day Notice requested relocation of the Laser Marking Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.

P970020/S012**

4/22/99

ACS Multi-Link RX Duet CSS and ACS Multi-Link OTW Duet CSS

Guidant Corporation

Vascular Intervention Group

Temecula, CA

92591-4628

The 30-Day Notice requested that "end-product" pyrogen testing be performed on non-sterile samples prior to E-beam sterilization, in addition to the current method of testing sterile samples.

P970034S003**

4/16/99

UV-PMMA Posterior Chamber Intraocular Lenses

Ophthalmic Innovations International, Inc.

Claremont, CA

91711

The 30-day Notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at Griffith MicroScience, the same sterilization contractor approved in the original PMA. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase.