P010062

6/7/04

Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

Euclid Systems Corporation

Herndon, VA

20171

Approval for the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear.  The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes.  The lenses are indicated for overnight wear for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters.  The lenses may only be disinfected using a chemical disinfection system.  Note: To maintain the Orthokeratology effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule.  Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intended correction.

P020030

6/17/04

Stelid II Steroid eluting pacing leads, Models BTF25D, BTF26D, BJF24D, BJF25D, UTF25D, and UTF26D, Stelix steroid eluting pacing leads models BR45D and BR46D, Stelix II steroid eluting pacing leads model BRF25D and BRF26D

ELA Medical, Inc.

Plymouth, MN

55441

Approval for the Stelid II, Stelix, and Stelix II Endocardial Pacing Leads.  The Stelid II, Stelix, and Stelix II endocardial steroid eluting pacing leads are designed to be used with an implantable pacemaker for pacing and sensing of the heart.  The Stelid II models BTF25D/26D and UTF25D/26D are intended for permanent pacing and sensing of the ventricle.  The Stelid II models BJF24D/25D, Stelix models BR45D/46D, and Stelix II models BRF25D/26D are intended for permanent pacing and sensing of the atrium.

P030045

6/8/04

IntraStent® DoubleStrut™ Stent

ev3, Inc.

Plymouth, MN

55442

Approval for the IntraStent DoubleStrut Stent.  The device is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm.

P030054

6/30/04

St. Jude Medical®

Epic™ HF System

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the St. Jude Medical Epic^™ HF System and the St. Jude Medical^® Atlas^® + HF System. These systems are indicated for the following: The St. Jude Medical Epic HF and Atlas + HF Systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The Epic HF and Atlas + HF Systems are also intended to provide a 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% and a prolonged QRS duration.

P790017/S081

6/23/04

Real-Time

Sprinter Over-The-Wire (OTW) Balloon Dilatation Catheter (multiple model numbers for the 1.5 mm to 4.0 mm diameters)

Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Approval for minor design, packaging and labeling changes to the Stormer OTW Ballon Dilatation Catheter including the addition of 6 mm and 12 mm balloon lengths.  The device, as modified, will be marketed under the trade name Sprinter OTW Balloon Dilatation Catheter and is indicated as follows:  For balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.  The Sprinter OTW Balloon Dilatation Catheter (balloon models 2.5 mm – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.  Note: Bench testing was conducted with the Sprinter OTW Balloon Dilatation Catheter and marketed balloon expandable stents.  Consideration should be taken when this device is used with different manufacturers’ stents due to differences in stent design.

P790019/S018

6/16/04

Special

Device: Abbott AxSYM® HAVAB®-M Assay

Abbott Laboratores

Abbott Park, IL

60064

Approval for changes in the manufacturing process.

P810046/S216

6/18/04

180-Day

VOYAGER™ RX Coronary Dilatation Catheter

Guidant Corporation

Temecula, CA

92591

Approval for the VOYAGER™ RX Coronary Dilatation Catheter.  The device, as modified, is indicated for 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, 2) balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and 3) balloon dilatation of stent after implantation (Testing including the following Guidant stents: MULTI-LINK: PIXEL® and PENTA® and ZETA® Coronary Stent Systems).

P830061/S037

6/8/04

135-Day

Lead Models 4074, 4092, 4574, 4592

Medtronic, Inc.

Minneapolis, MN

55432

Approval to market these lead models manufactured using MED 2000 silicone adhesive.

P840001/S073

6/16/04

Real-Time

Itrel 3, Synergy and Synergy Vertitel Spinal Cord Stimulators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a new permanently implanted surgical lead (Model 3999 Hinged 2 x 4 Lead) to be used with Medtronics fully implantable neurostimulation systems for Spinal Cord Stimulation (P840001) or the external radio frequency neurostimulation systems for Spinal Cord Stimulation (K934065).

P840039/S053

6/14/04

Real-Time

Silicone and PMMA Intraocular Lenses and Ocucoat

Bausch & Lomb

San Dimas, CA

91773

Approval for the use of a 100% Ethylene Oxide sterilization method in products in their final packaged form.  Sterilization will occur at CosMed, Inc., Located in South Plainfield New Jersey.  The products affected by this change are the PMMA and silicone lenses and Ocucoat Viscoadherent manufactured at Bausch &  Lomb, Inc., Clearwater, Florida.

P850089/S053

6/8/04

135-Day

Lead Models 5092, 5592, 5554, 5594

Medtronic, Inc.

Minneapolis, MN

55432

Approval to market these lead models manufactured using MED 2000 silicone adhesive.

P860004/S061

6/4/04

Special

Synchromed Implantable Infusion System

Medtronic Neurological

Minneapolis, MN

55432

Approval for a change to the Medtronic Model 8840 N’Vision Programmer Technical Manual to add a precaution to identify an environment in which the device is not certified for use.

P860047/S016

6/14/04

Real-Time

Silicone and PMMA Intraocular Lenses and Ocucoat

Bausch & Lomb

San Dimas, CA

91773

Approval for the use of a 100% Ethylene Oxide sterilization method in products in their final packaged form.  Sterilization will occur at CosMed, Inc., Located in South Plainfield New Jersey.  The products affected by this change are the PMMA and silicone lenses and Ocucoat Viscoadherent manufactured at Bausch &  Lomb, Inc., Clearwater, Florida.

P880090/S020

6/14/04

Real-Time

Silicone and PMMA Intraocular Lenses and Ocucoat

Bausch & Lomb

San Dimas, CA

91773

Approval for the use of a 100% Ethylene Oxide sterilization method in products in their final packaged form.  Sterilization will occur at CosMed, Inc., Located in South Plainfield New Jersey.  The products affected by this change are the PMMA and silicone lenses and Ocucoat Viscoadherent manufactured at Bausch &  Lomb, Inc., Clearwater, Florida.

P900023/S040

6/28/04

Real-Time

ABIOMED® BVS5000 Bi-Ventricular Support System and AB5000™ Circulatory Support System

ABIOMED, Inc.

Danvers, MA

01923

Approval for the addition of two inflow cannulae (malleable 42 Fr. And 32 Fr.) to be added to the currently approved cannulae used with the BVS5000 Bi-Ventricular Support System and the AB5000™ Circulatory Support System.

P900023/S041

6/28/04

Real-Time

ABIOMED® BVS5000 Bi-Ventricular Support System and AB5000™ Circulatory Support System

ABIOMED, Inc.

Danvers, MA

01923

Approval for the addition of the Sewing Cuff for cannula placement for the use with the BVS5000 Bi-Ventricular Support System and the AB5000™ Circulatory Support System.

P900039/S013

6/7/04

180-Day

NeuGraft Collagen/

Hydroxyapatite Bone Graft Substitute

NEUCOLL, Inc.

Los Gatos, CA

95032

Approval for the addition of the product “NeuGraft®”.  Collagraft® Strip Bone Graft Matrix (Collagraft) was originally approved by the FDA on January 27, 1994 (review of P900039).  The product currently continues to be marketed by that name.  NeuGraft® is identical to Collagraft® Strip bone Graft Matrix, except that the brand name on the labeling is different.  The labeling for NeuGraft® indicated and explains that the two products are the same, but are sold through different distribution channels.  As proposed, the product will continue to be sold using both names Collagraft® and NeuGraft®.  There will be no change affecting safety and effectiveness for this product.

P910061/S011

6/14/04

Real-Time

Silicone and PMMA Intraocular Lenses and Ocucoat

Bausch & Lomb

San Dimas, Ca

91773

Approval for the use of a 100% Ethylene Oxide sterilization method in products in their final packaged form.  Sterilization will occur at CosMed, Inc., Located in South Plainfield New Jersey.  The products affected by this change are the PMMA and silicone lenses and Ocucoat Viscoadherent manufactured at Bausch &  Lomb, Inc., Clearwater, Florida.

P920014/S019

6/29/04

180-Day

HeartMate XVE LVAS

Thoratec Corporation

Pleasanton, CA

94588

Approval of the post approval study for the device.

P920015/S029

6/8/04

180-Day

Model 6949 and 6931 Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of a polyurethane overlay.

P920015/S030

6/8/04

180-Day

Model 6948 and 6930 Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of a polyurethane overlay.

P930016/S018

6/7/04

180-Day

STAR S4 ActiveTrak™ Excimer Laser System and WaveScan WaveFront® System

VISX, Inc.

Santa Clara, CA

95051

Approval for Software upgrade: WaveScan Software Version 3.5 changes from currently approved Version 3.07 (under P930016/S016) for VISX STAR S4 ActiveTrak™ Excimer Laser System for wavefront-guided LASIK treatments of myopic astigmatism up to

-6.00 D MRSE, with cylinder between 0.00 and -3.00 D.

P930039/S019

6/8/04

135-Day

Lead Models 4068, 4568, 5068, 5568

Medtronic, Inc.

Minneapolis, MN

55432

Approval to market these lead models manufactured using MED 2000 silicone adhesive.

P950014/S022

6/10/04

Real-Time

Prostatron™ Praktis

Urologix, Inc.

Minneapolis, MN

55447

Approval for design changes to include changing the contacts on the internal wiring from tin to gold and a modification to the software to include an additional alarm.  The device, as modified, will be marketed under the trade name Prostatron™ Praktis and is indicated for the treatment of benign prostatic hyperplasia (BPH).

P950032/S038

6/14/04

Real-Time

Apligraf

Organogenesis, Inc.

Canton, MA

02021

Approval to introduce a new cell strain into the production of Apligraf (i.e., HDF B700) and a modification of the methods for detecting Cytomegalovirus (CMV).

P960007/S017

6/28/04

180-Day

Transcyte

Smith & Nephew Wound Management

La Jolla, CA

92037

Approval for the termination of the post-approval study protocol entitle: “A randomized, controlled within-patient-paired study to compare the effectiveness of TransCyte and Biobrane in the treatment of mid-dermal to indeterminate depth burn wounds.”

P970004/S025

6/8/04

180-Day

Medtronic® InterStim® Sacral Nerve Stimulation System

Medtronic Gastroenterology/

Urology (MGU)

Shoreview, MN

55126

Approval of the post-approval study for the device.

D970012/S011

6/7/04

180-Day

AMS 700 Series Product Line Inflatable Penile Prostheses

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for removal of the disclaimer related to the trade name “InhibiZone” (i.e., “Zones of inhibition shown in laboratory data and have not been verified in clinical studies.”) and related changes to the labeling.

D970012/S023

6/7/04

Special

AMS 700 Series Product Line Inflatable Penile Prostheses with InhibiZone™ Antibiotic Surface Treatment

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for labeling modifications cautioning against the concomitant use of injection therapy for erectile dysfunction.

P970027/S001

6/30/04

Special

Abbott AxSYM® Anti-HCV

Abbott Laboratories

Abbott Park, IL

60064

Approval for changes in the manufacturing process.

P970043/S015

6/29/04

Panel

LADARVision® 4000 Excimer Laser System

Alcon Laboratories, Inc.

Orlando, FL

32826

Approval for the LADARVision® 4000 Excimer Laser System.  The device uses a 6.5 mm optical zone, a 9.00 mm ablation zone, is locked-out for treatments above

-9.75 diopters (d) sphere, -5.00D cylinder, and

-10.63D spherical equivalent (SE), and is indicated for wavefront-guided laser assisted in-situ keratomileusis (LASIK):  1) for the reduction or elimination of myopic astigmatism up to -8.00D sphere with -0.50 to -4.00D cylinder and up to

-8.00D SE at the spectacle plane; 2) in patients who are 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50D for a SE of up to -6.00

D and less than or equal to 0.75D for a SE greater than

-6.00D.

D980003/S004

6/25/04

Real-Time

Keramos™ Ceramic/

Ceramic Hip

Encore Medical, L.P.

Austin, TX

78758

Approval for removal of the rim from the Keramos™ acetabular shell.

P980016/S041

6/25/04

180-Day

Medtronic® Intrinsic 30 Model 7287 Dual Chamber Implantable Cardioverter Defibrillator (ICD) System with Model 9996 Application Software and Medtronic™ Intrinsic Model 7288 Dual Chamber Implantable Cardioverter Defibrillator (ICD) System with Model 9997 Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® Intrinsic 30 Model 7287 Dual Chamber Implantable Cardioverter Defibrillator (ICD) System with Model 9996 Application Software and Medtronic™ Intrinsic Model 7288 Dual Chamber Implantable Cardioverter Defibrillator (ICD) System with Model 9997 Application Software, which are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

P980035/S037

6/7/04

180-Day

Medtronic AT500 DDDRP Pacing System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for changes to the investigational plan for the Medtronic’s AT500 DDDRP Pacing System’s Post-Approval Study.

P980037/S009

6/22/04

Real-Time

AngioJet® Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for changes to the Pump Set (also called the Pump Set Plus) which included: 1) modification to the pump outlet and inlet fittings; 2) changes to the depth of the check ball seat and elimination of the check ball spring; 3) changes to the prime sensor cup; 4) changes to the piston head; 5) color changes to the luer; and 6) changes to the paratubing assembly.

P980037/S010

6/22/04

Real-Time

AngioJet®

Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for changes to the packaging specifically to the inner tray and outer pouch.

P980037/S011

6/30/04

Special

AngioJet® Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for the addition of a boxed warning regarding use in pulmonary vasculature to all Possis AngioJet Catheter Instruction for Use documents.

P990004/S006

6/28/04

Real-Time

Surgifoam Absorbable Gelatin Sponge

Ethicon, Inc.

Somerville, NJ

08876

Approval for revision on the labeling to include the use of the product with thrombin.

P990013/S004

6/23/04

Special

Staar Surgical UV-Absorbing Collamer Foldable Intraocular Lenses

Staar Surgical Company

Monrovia, CA

91016

Approval to modify the package insert.

P990026/S022

6/22/04

Real-Time

GlucoWatch G2 Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for multiple-patient use of the GlucoWatch G2 Biographer.

P990066/S017

6/7/04

180-Day

Senographe 2100D Full Field Digital Mammography System

GE Medical Systems

Milwaukee, WI

53188

Approval for a name change for the Senographe 2100D FFDM System to the Senographe DS FFDM System.

P000009/S012

6/22/04

Real-Time

The Belos, Tachos ATx, and Lexos Implantable Cardioverter Defibrillator Families and Cardiac Airbag

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for changes to the current FDA-approved labeling for BIOTRONIK Implantable Cardioverter Defibrillators.

P000018/S040

6/10/04

180-Day

Novoste™ Beta-Cath™ 3.5F System

Novoste Corp.

Norcross, GA

30093

Approval for the Beta-Rail 3.5F Delivery Catheter with distal improvements, and a change in the Procedure Accessory Pack.

P000028/S005

6/18/04

Special

AFFINITY™ Anterior Cervical Cage System

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for an alternative surgical technique in which the reaming step is removed from the surgical procedure.

P000054/S001

6/10/04

Real-Time

INFUSE™ Bone Graft

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for

1) an increase in the expiration date of the 4.2 and 12 mg vialed rhBMP-2 component of the referenced devices from 36 to 48 months;

 2) an increase in the expiration date of the commercial kit component from 24 to 36 months; and

3) the protocol to be followed for all future expiration date changes.

P000058/S010

6/10/04

Real-Time

INFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for

1) an increase in the expiration date of the 4.2 and 12 mg vialed rhBMP-2 component of the referenced devices from 36 to 48 months;

 2) an increase in the expiration date of the commercial kit component from 24 to 36 months; and

3) the protocol to be followed for all future expiration date changes.

P010031/S013

6/23/04

Real-Time

Model 7303 InSync Maximo Dual Chamber ICD system and Model 9998 Application Software Version 1.0 for the Model 2090 Programmer system

Medtronic, Inc.

Minneapolis, MN

55432

Model 7303 InSync Maximo Dual Chamber ICD system and Model 9998 Application Software Version 1.0 for the Model 2090 Programmer system.

P010031/S014

6/24/04

180-Day

Medtronic® InSync II Protect Model 7295 Implantable Cardioverter Defibrillator (ICD) System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC), Juncos, Puerto Rico.

P020004/S006

6/2/04

180-Day

Gore EXCLUDER™ Bifurcated Endoprosthesis

W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Approval for a low permeability  version of the Gore EXCLUDER Bifurcated Endoprosthesis.

P020014/S005

6/10/04

180-Day

Essure™ System

Conceptus, Inc.

San Carlos, CA

94070

Approval for the device labeling to include 3-year effectiveness results and other labeling changes.

P020025/S004

6/9/04

180-Day

EPT-1000 XP Cardiac Ablation System

EP Technologies, Inc.

San Jose, CA

95134

Approval for a change in design of the EPT-1000 XP Cardiac Ablation Controller.  The change in design incorporates the originally approved EPT-1000 XP Controller with Track While Ablate (TWA) technology to visualize catheter navigation during RF energy delivery using the Real Time Position Management (RPM) system.  The device, as modified, will be marketed under the trade name Track While Ablate (TWA) EPT-1000 XP Cardiac Ablation System.  The TWA EPT-1000 XP Cardiac Ablation Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

P020026/S008

6/14/04

Real-Time

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 a modification to the residual solvent test method for the Cypher™ Sirolimus-eluting Coronary Stent.

P020045/S005

6/10/04

Real-Time

7F Freezor® Cardiac CryoAblation Catheter and CCT.2 CryoConsole System

CryoCath Technologies, Inc.

Quebec, Canada

H9H 5H3

Approval for modifications to the Freezor® and Freezor® Xtra cryoablation systems.

P020050/S001

6/4/04

180-Day

WaveLight ALLEGRETTO WAVE™ Excimer Laser System

WaveLight Laser Technologie AG

Earlangen, Germany

91058

Approval for a manufacturing site located at WaveLight Laser Technologie AG, Pressath, Germany.

P030005/S002

6/28/04

Special

CONTAK RENEWAL TR (model H120 and H125)

Guidant Corporation Cardiac Rhythm Management

St. Paul, MN

55112

Approval for minor labeling changes to the CRT-P device.

P030008/S001

6/4/04

180-Day

WaveLight ALLEGRETTO WAVE™ Excimer Laser System

WaveLight Laser Technologie AG

Earlangen, Germany

91058

Approval for a manufacturing site located at WaveLight Laser Technologie AG, Pressath, Germany.

P810025/S023

6/4/04

Amvisc TM and Amvisc TM Plus

Bausch and Lomb

San Dimas, CA

91773

Addition of a new quality control test method for the Amvisc TM and the Amvisc TM Plus.

P860019/S200

6/10/04

Maverick Monorail PTCA Catheter System and Maverick2 Monorail PTCA Catheter System

Boston Scientific

Maple Grove, MN

55311

Change in the manufacturing process to propose alternative parameters for laser welding of the port bond on the Maverick™ Monorail and Maverick™2 Monorail PTCA Catheter Systems.

P900056/S081

6/18/04

Rotablator Rotational Angioplasty System

Boston Scientific Corporation

Maple Grove, MN

55311

Reduction in test frequency for in-process, destructive package testing.

P940040/S004

6/23/04

AMPLICOR® Mycobacterium tuberculosis (MTB) Test

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Change in process points at which chemical and functional testing are performed.

P000046/S009

6/4/04

Staarvisc II, Shellgell, and CoEase

Anika Therapeutics, Inc.

Woburn, MA

01801

Addition of a Quality Test Method for Staarvisc II, Shellgel and CoEase.

P000052/S025

6/10/04

GALILEO Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Discontinue the preventative maintenance program on the head and base components of the GALILEO Source Delivery Unit (SDU).

P030017/S001

6/28/04

Precision™ Spinal Cord Stimulator System

Advanced Bionics Corporation

Sylmar, CA

91342

Addition of a larger sterilization chamber.

P030019/S004

6/4/04

Orthovisc® High Molecular Weight Hyaluranon

Anika Therapeutics, Inc.

Woburn, MA

01801

Addition of a new quality control test.

P030026/S001

6/14/04

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

Ortho-Clinical Diagnostics

Rochester, NY

14626

Change in the manufacturing equipment and manufacturing process steps acceptance criteria associated with this equipment change.