P010061

7/28/04

CureLight BroadBand (Model CureLight 01)

PhotoCure ASA

Oslo, Norway

N-0377

Approval for the CureLight BroadBand (model CureLight 01).  The device is indicated for use in combination with TRADENAME cream for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate.

P030012

7/8/04

ImageChecker® CT CAD Software System – Model LN-1000

R2 Technology, Inc.

Sunnyvale, CA

94087

Approval for the ImageChecker CT CAD Software System – Model LN-1000.  This software system is indicated to assist radiologists in the detection of solid pulmonary nodules during review of multidetector CT (MDCT) scans of the chest.  It is intended to be used as an adjunct, alerting the radiologist – after his or her initial reading of the scan – to regions of interest (ROIs) that may have been initially overlooked.

P040008

7/8/04

VIDAS TPSA assay

bioMerieux, Inc.

Hazelwood, MO

63042

Approval for the VIDAS TPSA assay indicated as follows: VIDAS TPSA is intended for use with a VIDAS (VITEK ImmunoDiagnostic Assay System) instrument as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantitative measurement of total prostate specific antigen in human serum.  The VIDAS TPSA assay is indicated as an aid in the management of patients with prostate cancer and as an aid in the detection of prostate cancer in conjunction with digital rectal examination (DRE) in men age 50 years or older.  Prostate biopsy is required for diagnosis of prostate cancer.

P780012/S014

7/30/04

Special

Abbott AxSYM® HAVAB® 2.0

Abbott Laboratories

Abbott Park, IL

60064

Approval for changes in the manufacturing process.

P810046/S215

7/16/04

180-Day

RX CHASSIS 3™ Coronary Dilation Catheter

Guidant Corporation

Temecula, CA

92591

Approval for the RX CHASSIS 3™ Coronary Dilation 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, and 2) balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.

P830055/S088

7/1/04

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for the addition of cemented posterior stabilized (PS) femoral components and tibial bearing components to the existing LCS Total Knee System.  That is, the addition of the LCS Complete M1 PS components (sizes standard, standard+, and large).  The LCS Complete M1 PS Cemented Femoral component combines features of the previously approved LCS PS and LCS Complete femoral components and also includes modification to the geometry and position of the anterior and posterior femoral cams. Along with associated modification to the length of the patello-femoral articulation.  The LCS Complete M1 PS Tibial Insert component combines features of the previously approved LCS PS and LCS Complete RP tibial bearing components and  is modified to accommodate the changes in anterior and posterior femoral cam geometry.

P880086/S100

7/21/04

180-Day

Model 3150 Pacing System Analyzer Wand and the Model 3307 v4.7 programmer software for use with Model 3510 programmers

St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Approval for the Model 3150 Pacing System Analyzer Wand and the Model 3307 v4.7 programmer software for use with Model 3510 programmers.

P890064/S015

7/29/04

Real-Time

Digene Hybrid Capture® 2 HPV DNA Test

Digene Corporation

Gaithersburg, MD

20878

Approval for revisions to the assay’s labeling performance characteristics section.  The change involves moving the section “Relative False-Positive and False-Negative Rate” from the labeling’s clinical performance section to the analytical section with narrative revisions.  The new section is entitled “External Study Using Clinical Specimens.”  A new note has been added to the current labeling’s Table 10 referenced to Snijders, PJF, van de Brule, AJC, and Meijer, CJLM, “The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivity”.  J Pathol 2003; 201: 1-6.

P920014/S023

7/8/04

Real-Time

Thoratec® HeartMate® XVE and VE Left Ventricular Assist System (LVAS)

Thoratec Corporation

Woburn, MA

01888

Approval for use of the PowerSonic sealed lead acid battery (model PS-1223) as a replacement for the no longer manufactured Panasonic sealed lead acid battery (model LC-SA122R3EU) as a source of battery power to drive the HeartMate VE and ZVE left ventricular assist systems.

P920023/S015

7/22/04

180-Day

Urolume® Endourethral Prosthesis for Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval to conclude the benign Prostatic Hypertrophy Portion of the Urolume® post-approval study and to include the probability of explant due to tissue response at 10 years in the labeling.

P920047/S024

7/27/04

Real-Time

Blazer II XP and Blazer XP RPM Catheters

Boston Scientific Corporation

San Jose, CA

95134

Approval  for the elimination of excess wiring in the subassembly of the Blazer II XP and Blazer XP RPM Catheters.

P950002/S014

7/1/04

Real-Time

BAK™ VISTA™ Interbody Fusion Cage

Zimmer Spine

Minneapolis, MN

55439

Approval to add the following sizes to the BAK™ VISTA™ device: 9x24 mm, 11x24 mm, 13x24 mm, 15x24 mm, 17x24 mm, 19x24 mm.  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 levels.  These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.  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 would be skeletally mature and have had six months of non-operative treatment.

P950029/S020

7/15/04

Real-Time

Symphony and ELA Rhapsody Pacemakers

ELA Medical, Inc.

Plymouth, MN

55441

Approval for uncoated versions of the Symphony and ELA Rhapsody pacemakers.

P960009/S029

7/16/04

Real-Time

Medtronic Models 3387 and 3389 DBS Lead Kits, Models 7482 and 7495 Extension Kits for DBS, and Model 3550-09 Accessory Kit

Medtronic Neurological

Minneapolis, MN

55432

Approval to incorporate a polyether urethane material change to the approved Medtronic Models 3387 and 3389 DBS Lead Kits, Models 7482 and 7495 Extension Kits for DBS, and Model 3550-09 Accessory Kit.

P960043/S054

7/15/04

Real-Time

Perclose® A-T and ProGlide™ 6 French Suture Mediated Closure (SMC) Systems

Abbott Vascular Devices

Redwood City, CA

94063

Approval for modified sheath and foot assemblies on the Perclose A-T and ProGlide devices and the addition of a suture cutter on the Perclose A-T device.

P960058/S034

7/19/04

180-Day

HiResolution™ Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for an alternate electrode configuration for the HiRes90K implant.  This alternate electrode is a modified version of the current HiFocus Electrode, identified as HiFocus Helix Electrode.

P960058/S037

7/23/04

Special

HiResolution™ Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for expansion of the in-process inspection procedure for the HiRes 90K implant.  Namely, the PMA supplement proposed to add an additional visual inspection step to ensure weld integrity by using a minimum of 80X magnification to verify the following: 1) complete closure of the weld hold,

2) acceptable weld quality, and

3) absence of foreign material at the weld site.

D970012/S019

7/14/04

180-Day

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

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for a modified pump design (the AMS 700 Tactile Pump).

D970012/S022

7/14/04

Special

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

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for the use of additional acceptance criteria for the yarn and woven fabric used in the CX/CXR/Ultrax penile prosthesis cylinders.

P970040/S003

7/30/04

ACHILLES EXPRESS

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Madison, WI

53717

Approval for a manufacturing site located at GE Medical Systems China Co., Ltd., Jiansgu, P.R. China.

P980012/S006

7/21/04

Real-Time

World Heart Novacor N100PC and N100PCq :VAS

World Heart, Inc.

Oakland, CA

94621

Approval for modifications to the device system labeling; specifically, changes to (only) the Device Reliability portion of section 7 (Clinical Study) of the Physician’s Manual.

P980023/S018

7/27/04

Real-Time

Kentrox RV Steroid and Kentrox SL Steroid Implantable Cardioverter Defibrillator (ICD) Leads

Biotronic, Inc.

Lake Oswego, OR

97035

Approval for addition of the steroid collar to the distal end of the lead.  The device, as modified, will be marketed under the trade name Kentrox SL Steroid and Kentrox RV Steroid and is indicated for use in conjunction with a BIOTRONIK ICD.

P980031/S008

7/8/04

180-Day

INTACS® Prescription Inserts

Addition Technology

Sunnyvale, CA

94089

Approval for a manufacturing site located at Addition Technology, Inc., Sunnyvale, California.

P980037/S008

7/15/04

Real-Time

AngioJet® Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for changes to AngioJet XMI Catheter which included: 1) addition of a proximal marker band; 2) changes to the proximal shaft; and 3) changes to the strain relief.

P990001/S015

7/12/04

Real-Time

Vitatron T60 DR and T20 SR Systems

Vitatron

Minneapolis, MN

55432

Approval for the Vitatron T60 DR and T20 SR Systems, which consist of the following: 1) The Vitatron T60 DR system includes the Vitatron T60 DR Model T60A1, the VSF07/VSF08 version 1.0 application software, and the Vitatron Desktop Model VSH03/VSH04 version 2.0 SR1. 2) The Vitatron T20 SR system includes the Vitatron T20 SR Model T20A1, the VSF07/VSF08 version 1.0 application software, and the Vitatron Desktop Model VSH03/VSH04 version 2.0 SR1.  NOTE: The above referenced application software and desktop will be distributed on the Model VSE03/VSE04 version 2.0 CD-ROM.

P990004/S005

7/29/04

180-Day

SURGIFOAM Absorbable Gelatin Sponge

Johnson & Johnson Wound Management

Somerville, NJ

08876

Approval for a manufacturing site located at Isotron PLC, Daventry, United Kingdom.

P990037/S021

7/14/04

Real-Time

Vascular Solutions Duett Pro Sealing Device (models 1000 and 1010) and Diagnostic Duett Pro Sealing Device (models 220 and 2210)

Vascular Solutions, Inc.

Minneapolis, MN

55369

Approval for modifying the pressure relief valve component on the catheter and replacing the mixing 20 gauge needle syringe with a needleless non-coring vial access device.

P990037/S022

7/9/04

180-Day

Duett Pro Sealing Device Model 1010

Vascular Solutions, Inc.

Minneapolis, MN

55369

Approval for a manufacturing site located at Steris Corp., Isomedix Services, Minneapolis, Minnesota.

P000058/S002

7/29/04

180-Day

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

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for 1) the extension of the levels of use of the device from L4-S1 to L2-S1 2) modification of the indication to allow for the device to be used in subjects who may have retrolisthesis in conjunction with degenerative disc disease 3) change in storage temperature limit and 4) revisions to instruction for use.

P010012/S030

7/21/04

Special

Finishing Wire® Universal

Guidant Corporation

St. Paul, MN

55112

Approval for adding instructions in the labeling to continue fluoroscopy during removal of the guiding catheter.

P010049/S011

7/1/04

Real-Time

QuickSeal SureStat Arterial Closure System

Sub-Q, Inc.

San Clemente, CA

92673

Approval to add Thrombin to the hemostatic pledget.  The device, as modified, will be marketed under the trade name QuickSeal SureStat Arterial Closure System and is indicated for “…delivery of T-foam for extravascular closure of the femoral artery access sites.  The system is indicated for use in reducing time to hemostasis at femoral artery puncture sites and in reducing time to ambulation in patients who have undergone diagnostic or interventional procedures using 8 French or smaller procedural sheaths.  The device reduces time to eligibility for hospital discharge in patients who have undergone diagnostic or interventional procedures and reduces time to actual hospital discharge in patients who have undergone diagnostic procedures.”

P020003/S003

7/28/04

Special

Mentor Saline-Filled Testicular Prosthesis

Mentor Corporation

Santa-Barbara, CA

93111

Approval to add a cautionary statement to the outer packaging specifying that the device should be filled with saline prior to implantation.

P020014/S006

7/22/04

180-Day

Essure™ System

Conceptus, Inc.

San Carlos, CA

94070

Approval for modification of a warning statement in the Essure physician labeling regarding thermal endometrial ablation in women with Essure micro-inserts in place.

P020018/S004

7/15/04

180-Day

H&LB One-Shot Delivery system for use with the Zenith FLEX AAA Endovascular Graft

Cook, Inc.

Bloomington, IN

47402

Approval for modifications made to the H&LB One-Shot Delivery System.

P020023/S008

7/23/04

Special

Restylane

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Approval for the product box label to say “Syringe contents are sterile”.

P020025/S005

7/7/04

180-Day

EPT-1000 XP Cardiac Ablation System

Boston Scientific

San Jose, CA

95134

Approval for a manufacturing site located at Plexus Service Corporation, Bothell, Washington.

P020025/S006

7/27/04

Real-Time

EPT-1000 XP Cardiac Ablation System

Boston Scientific

San Jose, CA

95134

Approval for the elimination of excess wiring in the subassembly of EPT-1000 XP Catheters.

P020045/S003

7/19/04

Real-Time

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

Applied Physics CryoCath Technologies, Inc.

Brookline, MA

02445

Approval for a design change to the 7F Freezor Cardiac CryoAblation catheter Y-block.

P810025/S024

7/16/04

Amvisc™ & Amvisc™ Plus

Bausch & Lomb

San Dimas, CA

91773

Elimination of the owl monkey test for inflammatory potential of bulk and finished product formulation of Amvisc™ & Amvisc™ Plus.

P830060/S055

7/6/04

Lead Adapters, Model Numbers 6833, 6836, and 6931

Guidant Corporation

St. Paul, MN

55112

Change in the supplier for the mold release, a change in the type of lubricant, and a change in the process of applying the lubricant.

P900060/S029

7/2/04

CarboMedics Prosthetic Heart Valve (CPHV)

CarboMedics, Inc.

Austin TX

78752

Change in the manufacturing process to the sterilization parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in a biological indicator.

P910073/S046

7/6/04

Lead Adapters, Model Numbers 6833, 6836, and 6931

Guidant Corporation

St. Paul, MN

55112

Change in the supplier for the mold release, a change in the type of lubricant, and a change in the process of applying the lubricant.

P930031/S022

7/22/04

Wallstent (TIPS and Venous) Endoprosthesis With Unistep Plus Delivery System

Boston Scientific Corporation

Maple Grove, MN

55311

Reduction in bond cure times for two processing steps used in the manufacture of the stent delivery catheter for the above-stated devices.

P970015/S028

7/19/04

Inter Fix™ Threaded Fusion Device

Medtronic Sofamor Danek

Memphis, TN

38132

Change of sterilization validation methods for the Inter Fix™ Threaded Fusion Device.

P980033/S011

7/22/04

Wallstent (TIPS and Venous) Endoprosthesis With Unistep Plus Delivery System

Boston Scientific Corporation

Maple Grove, MN

55311

Reduction in bond cure times for two processing steps used in the manufacture of the stent delivery catheter for the above-stated devices.

P980041/S005

7/15/04

Access® AFP Reagents on the Access Immunoassay Analyzer

Beckman Coulter, Inc.

Chaska, MN

55318

Changes in the manufacturing process to the reagent pack intermediate components for the Access® AFP reagents on the Access Immunoassay Analyzer.

P000014/S008

7/16/04

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Removal of the in-process testing of the formulated calibrator before dispensing into vials since the test is repeated during the quality control release of the Anti-HBs Reagent Pack and Calibrators.

P000029/S008

7/9/04

Deflux Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Change from washing manufacturing equipment manually to use of a dishwasher.  In addition, the supplement covers the elimination of the use of detergent to use of water only.

P000029/S009

7/30/04

Deflux Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Change in a test site.

P000046/S010

7/16/04

Staarvisc, Shellgel, and CoEase

Anika Therapeutics, Inc.

Woburn, MA

01801

Change in procedure for the Quality Control Test Method (Owl Monkey Test) for Staarvisc II, Shellgel and CoEase.

P010021/S002

7/16/04

VITROS Immunodiagnostic Products Anti-HCV

Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Removal of the in-process testing of the formulated calibrator before dispensing into vials since the test is repeated during the quality control release of the Anti-HCV Reagent Pack and calibrators.

P010021/S003

7/30/04

VITROS Immunodiagnostic Products Anti-HCV

Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Change in the manufacturing equipment and manufacturing process steps acceptance criteria associated with this equipment change.  The proposed changes affect the manufacturing of VITROS Immunodiagnostic Products Anti-HCV Reagent Pack.

P020023/S007

7/7/04

Restylane Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Change in the cleaning process.

P020040/S001

7/2/04

NIRFLEX™ Premounted Coronary Stent System

Medinol, Inc.

Boston, MA

02109

Modification to the stent electro-polishing process.

P030019/S005

7/14/04

Orthovisc®, High Molecular Weight Hyaluronate

Anika Therapeutics, Inc.

Woburn, MA

01801

Change in a quality control method for Orthovisc, High Molecular Weight Hyaluronate.