P030029

5/14/04

ADVIA Centaur® Anti-HBs ReadyPack Reagents,

ADVIA Centaur® Anti-HBs ReadyPack Calibrators

Bayer HealthCare LLC

Tarrytown, NY

10591

Approval for the ADVIA Centaur Anti-HBs ReadyPack Reagents and

ADVIA Centaur Anti-HBs ReadyPack Calibrators.  The device is indicated for the qualitative determination of total antibodies to hepatitis B surface antigen in human serum or plasma (EDTA or heparinized) using the ADVIA Centaur System.  The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown.  Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV  disease associated with HBV infection.  A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology in unknown.

P030035

5/13/04

St. Jude Frontier™ Biventricular Cardiac Pacing System including the Frontier™ Model 5508 and 5508L Pulse Generators, the Aescula™ LV Model 1055K Lead and the Model 3307 v4.4.2m programmer software for use with the Model 3500/3510 Programmer

St. Jude Medical

Sylmar, CA

91342

Approval for the St. Jude Frontier Biventricular Cardiac Pacing System.  The Frontier Biventricular Pacing System is indicated for maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure.

P800022/S052

5/11/04

180-Day

CosmoDerm and CosmoPlast Human-Based Collagen

Inamed Corporation

Santa Barbara, CA

93111

Approval for a new raw material supplier for the human collagen component of CosmoDerm and CosmoPlast (i.e., Immucor/Gamma Biologicals of Houston, Texas).

P8400039/S054

5/27/04

180-Day

OcuCoat, PMMA and Silicone Intraocular Lenses

Bausch & Lomb, Inc.

Sam Dimas, CA

91773

Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey.

P860040/S016

5/28/04

180-Day

BioCurve Soft Contact Lenses

Cal Bionics, Inc.

Novato, CA

94947

Approval to relocate some manufacturing processes to the site located at American BioCurve, Inc., San Diego, California.

P860047/S018

5/27/04

180-Day

OcuCoat, PMMA and Silicone Intraocular Lenses

Bausch & Lomb, Inc.

Sam Dimas, CA

91773

Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey.

P880090/S021

5/27/04

180-Day

OcuCoat, PMMA and Silicone Intraocular Lenses

Bausch & Lomb, Inc.

Sam Dimas, CA

91773

Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey.

P890064/S014

5/4/04

180-Day

Digene Hybrid Capture® 2 High-Risk HPV DNA Test

Digene Corporation

Gaithersburg, MD

20878

Approval to include the optional use of an automated, high-throughput robotic pipetting and microplate handling system known as the Digene Rapid Capture System (RCS).

P900009/S019

5/7/04

Real-Time

Exogen 2000+

Smith & Nephew, Inc.

Memphis, TN

38116

Approval for the addition of 2 diodes in series with the positive lead of the 5-cell battery pack on the Exogen 2000+ Low Intensity Ultrasound Fracture Healing System.

P910023/S073

5/12/04

Real-Time

Housecall Plus™ Transtelephonic Monitoring System with Model 3180-T Transmitter and Model 3180-R Receiver Software (Version 2.0)

St. Jude Medical

Sunnyvale, CA

94086

Approval for software modifications to the St. Jude Medical Housecall Plus™ Receiver software (version 2.0) which also includes the support for the St. Jude Medical Epic and Atlas ICD families.

P910061/S012

5/27/04

180-Day

OcuCoat, PMMA and Silicone Intraocular Lenses

Bausch & Lomb, Inc.

Sam Dimas, CA

91773

Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey.

P910065/S005

5/25/04

180-Day

ST AIA-PACK PA

TOSOH Bioscience, Inc.

S. San Francisco, CA

94080

Approval of the TOSOH ST AIA-PACK PA assay to be used on the TOSOH AIA-360 and TOSOH AIA-1800 Automated Immunoassay Systems, members of the TOSOH AIA Automated Immunoassay System family.  The device, as modified, will be marketed under the same trade name ST AIA-PACK PA and is indicated for:  ST AIA-PACK PA is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA Nex*IA, AIA-600 II, AIA-1800 and AIA-360 analyzers.  This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older.  Prostate biopsy is required for the diagnosis of cancer.  This device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer.

P920047/S023

5/18/04

Real-Time

Blazer RPM Cardiac Ablation Catheter

Boston Scientific Corporation

San Jose, CA

95134

Approval for a change in the expiration date from one-year to three-years.

P960040/S043

5/4/04

Real-Time

VITALITY® 2 System Guide

Guidant Corporation

St. Paul, MN

55112

Approval for minor updates to the VITALITY® 2 System Guide Clinical Section.

D970012/S021

5/7/04

Real-Time

AMS 700 Series Product Line Inflatable Penile Prostheses

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for the addition of 4 cm, 5 cm and 6 cm rear tip extenders (RTEs) for the AMS 700 CXT cylinders.

P970018/S007

5/28/04

PrepStain™ System

TriPath Imaging

Redmond, WA

98052

Approval for modified labeling of the PrepStain System for use with an alternate specimen collection device.

P970051/S027

5/18/04

Real-Time

Nucleus 24 Cochlear Implant System with Nucleus 24 Contour Advance/Softip II Electrode and Insertion Tool

Cochlear Americas

Englewood, CO

80112

Approval for an electrode insertion tool to facilitate placement of the electrode into the cochlea as well as minor modifications to the Softip electrode to optimize its interaction with the insertion tool.  The device, as modified, will be marketed under the trade name Insertion Tool for the Nucleus 24 Contour Advance/Softip Electrode II.

P970053/S008

5/28/04

Real-Time

Nidek EC-5000 Excimer Laser System

Nidek, Inc.

Freemont, CA

94539

Approval to replace the 60Hz eyetracker with the 200 Hz eyetracker in the Nidek EC-5000 Excimer Laser System for the treatment of myopia and myopic astigmatism.

P980007/S004

5/7/04

Real-Time

Abbott ARCHITECT Free PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval for addition of the Architect Free PSA to the i2000_sr Platform, a member of the ARCHITECT® i2000 instrument family.  The device, as modified, will be marketed under the trade name Architect Free PSA and is indicated for the quantitative determination of free prostate specific antigen (PSA) in human serum.  The Architect Free PSA is intended to be used in conjunction with the Architect Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and DRE non-suspicious for cancer to determine the % free PSA value.  The Architect % free PSA value can be used as an aid in discriminating between prostate cancer and benign disease.

P980037/S007

5/5/04

180-Day

Possis AngioJet® Rheolytic™ Thrombectomy System

Possis Medical, Inc.

Minneapolis, MN

55433

Approval for the XMI® Rapid Exchange (XMI-RX) Catheter, a modification of the XMI-OTW Catheter.  The device, as modified, will be marketed under the trade name Possis AngioJet® XMI® Rapid Exchange Rheolytic™ Thrombectomy System, and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels >=2.0 mm in diameter prior to balloon angioplasty or stent placement.

P980049/S015

5/4/04

Real-Time

Elaview 1.22 UG application software

ELA Medical, LLC

Plymouth, MN

55441

Approval for two addition features (Telassistance and Clinical Registry) to the Elaview 1.22 UG application software.

P990023/S003

5/26/04

Special

Cellugel Ophthalmic Viscosurgical Device

Alcon Laboratories

Fort Worth, TX

76134

Approval to add syringe assembly illustrations and instructions to the labeling.

P000025/S012

5/14/04

180-Day

MED-EL COMBI 40+ Cochlear Implant System with MED-EL CI.STUDIO+ release version 2.0 Software

MED-EL Corporation

Durham, NC

27713

Approval for MED-EL CI.STUDIO+ release version 2.0 Software for the MED-EL COMBI 40+ Cochlear Implant System.

P000049/S012

5/10/04

Special

CardioSEAL® Septal Occlusion System with QwikLoad™

Nitinol Medical Technologies, Inc.

Boston, MA

02210

Approval for the addition of a warning to the labeling that protamine sulfate should not be used for heparin reversal because of the potential for thrombus formation.

P000052/S024

5/4/04

Special

GALILEO® Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for the addition of a secondary wipe station to the manufacturing process for the GDT-P32-1 Source Wires.

P000053/S004

5/7/04

Real-Time

AMS Sphincter 800™ Urinary Prosthesis

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for a new manufacturing procedure to produce the cuff backing, a design change to the thickness of the cuff backing, a material change in the silicone, and a promotional claim regarding the cuff wear characteristics of the modified design.

P010003/S003

5/3/04

Real-Time

BioGlue Surgical Adhesive in syringe delivery system (Model BG3500)

CryoLife, Inc.

Kennesaw, GA

30144

Approval for a disposable dual-barrel piston-driven syringe dispensing system as an alternate to the current dual-barrel reusable ratcheting piston-driven cartridge system.  The device, as modified, will be marketed under the trade name BG3500 and is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral, and carotid arteries).

P010017/S004

5/12/04

180-Day

SenoScan Full Field Digital Mammography System

Fisher Imaging Corporation

Denver, CO

80241

Approval for changes in the x-ray filter, skin line algorithm, Operator’s Manual and QC Manual changes under MQSA.

P010030/S005

5/3/04

Real-Time

LifeVest WCD 3000S

Lifecor, Inc.

Pittsburg, PA

15321

Approval for modifications to the LifeVest WCD 3000 device to better facilitate short-term use.  The device, as modified, will be marketed under the trade name LifeVest WCD 3000S and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.  The LifeVest WCD 3000S system is intended for short-term use in a medically supervised environment.  The device is not intended to be worn home.

P010031/S012

5/28/04

180-Day

Medtronic InSync ICD Model 7272 and Model 9969 Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for 1) changes to the investigational plan and implant forms of the post-approval study and 2) the addition of the InSync Model 7277 with Model 9983 Application Software to the study.

P010032/S011

5/5/04

180-Day

Genesis Neurostimulation (IPG) System

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for a manufacturing site located at Advanced Neuromodulation Systems, Inc., Plano, Texas.

P010038/S006

5/21/04

180-Day

iCAD System

iCAD, Inc.

Beavercreek, OH

45431

Approval for a manufacturing site located at ScanOptics, Inc, Manchester, Connecticut.

P010038/S007

5/19/04

Real-Time

iCAD System

iCAD, Inc.

Beavercreek, OH

45431

Approval for replacing the iCAD System’s CAD software with the Second Look CAD software and increasing the system memory from 1 Gigabyte to 2 Gigabytes.  The device, as modified, will be marketed under the trade name Second Look 200 and is indicated for:  Second Look is a computed system intended to identify and mark regions of interest on standard mammographic views, including views from patients with breast implants and images from qualified Full Field Digital Mammography systems, to bring to the attention of the radiologist after the initial reading has been completed.  Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

P010043/S001

5/26/04

180-Day

Lea’s Shield Barrier Contraceptive

Yama, Inc.

Union, NJ

07083

Approval for a manufacturing site located at Yama, Inc., Union, New Jersey.

P010049/S010

5/25/04

180-Day

QUICKSEAL SURESHOT Arterial Closure System

Sub-Q, Inc.

San Clemente, CA

92673

Approval to modify the design of the QuickSeal Arterial Closure System to allow the delivery of Q-Foam hemostatic sponge through an introducer delivery sheath and eliminate the depth market component.  The device, as modified, will be marketed under the trade name QuickSeal SureShot and is indicated for use in reducing time to hemostatis 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.

P020006/S004

5/26/04

180-Day

Enteryx Procedure Kit

Boston Scientific Corporation

Natick, MA

01760

Approval for a manufacturing site located at Life Science Outsourcing, Brea, California.  Final assembly of the Enteryx injector and the kitting procedures will be performed at this facility.

P020009/S015

5/5/04

Special

Express2 Monorail and Over-the-Wire Coronary Stent Systems

Boston Scientific Corporation

Natick, MA

01760

Approval to implement the following:  1) The addition of an additional in-process inspection,  2) Modification of a current in-process inspection, and  3) Modification of a manufacturing process to address complaints related to failure of the delivery system balloon to properly deflate following stent deployment.

P020045/S004

5/3/04

Real-Time

Freezor Cardiac Cryoablation Catheter

CryoCath Technologies, Inc.

Quebec, Canada

H9H 5H3

Approval for modifications made to the Freezor Cardiac Cryoablation catheter approved under P020045.

P030025/S002

5/5/04

Special

TAXUS Express2™ Monorail™ and Over-the-Wire Coronary Stent Systems

Boston Scientific Corporation

Natick, MA

01760

Approval to implement the following:  1) The addition of an additional in-process inspection,  2) Modification of a current in-process inspection, and  3) Modification of a manufacturing process to address complaints related to failure of the delivery system balloon to properly deflate following stent deployment.

P830060/S054

5/14/04

VENTAK®, Bipolar Endocardial Leads

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P890061/S014

5/14/04

VENTAK P

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P910073/S045

5/14/04

ENDOTAK®, ENDOTAK ENDURANCE, ENDOTAK RELIANCE

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P910077/S045

5/14/04

VENTAK PRx, VENTAK MINI®

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P930031/S021

5/7/04

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

Boston Scientific

Natick, MA

01760

Change in the manufacturing material used in the manufacture of the exterior tube for the device.

P930035/S012

5/14/04

VENTAK P2, VENTAK P3

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P940031/S031

5/14/04

VIGOR®, DISCOVERY®, MERIDIAN®

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P950001/S011

5/14/04

SELUTE®, SELUTE PICOTIP

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P960004/S025

5/14/04

FINELINE®, FINELINE II

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P960006/S010

5/14/04

SWEET TIP® Rx, SWEET PICOTIP® Rx, FLEXTEND®

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P960040/S044

5/14/04

VENTAK AV, VENTAK VR, VENTAK PRIZM™, VITALITY®, VITALITY 2

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P960058/S035

5/14/04

Hiresolution and Clarion CII Bionic Ear Systems

Advanced Bionics Corporation

Sylmar, CA

91342

Expansion of sterilization capacity using an alternate sterilization chamber.

D970003/S028

5/14/04

PULSAR®, PULSAR MAX, INSIGNIA®

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P970004/S028

5/27/04

Medtronic Interstim Therapy for Urinary Control, Lead Models 3080, 3886, 3889, 3092, 3093, 3966, and 3095

Medtronic Gastroenterology and Urology

Shoreview, MN

55126

Change in the supplier of raw materials used to manufacture the products.

P980033/S010

5/7/04

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

Boston Scientific

Natick, MA

01760

Change in the manufacturing material used in the manufacture of the exterior tube for the device.

P980044/S001

5/27/04

Supartz®

Smith & Nephew, Inc.

Memphis, TN

38116

Change in the carton packaging process for Supartz® from manual to automated.

P990038/S006

5/3/04

DiaSorin ETI-MAK-2-PLUS

DiaSorin S.p.A.

Stillwater, MN

55082

Change in the quality control tests used to determine specific attributes of incoming materials.

P990038/S008

5/19/04

DiaSorin ETI-MAK-2 PLUS

DiaSorin S.p.A.

Stillwater, MN

55082

Change in the manufacturing materials used to produce the ETI-MAK-2 PLUS Tracer Diluent.  This change was to add inactivated horseradish peroxidase, 2.5 mg/L, to the ETI-MAK-2 PLUS Tracer Diluent.

P000010/S003

5/6/04

AMPLICOR® HCV Test v2.0

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Incorporation of a terminal 0.2 µm filtration step to the Avidin-Horseradish Peroxidase (HRP) BGG Conjugate reagent manufacturing process.  The submission identified the change for which the approval is being requested and provides the rationale for the change.

P000014/S007

5/14/04

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Replacement of key equipment used in performing the Coated Well test Procedure and the acceptance criteria associated with its use.  In addition, the coated well sampling plan, randomization methods for sampling, and test error correction methods have been improved to further ensure batch quality and reduce production waste.  The Coated Well Test Procedure is used to verify an acceptable level of well-to-well precision and outlier-level incidence in the coated wells manufactured for the VITROS Anti-HBs Assay.

P000049/S013

5/14/04

CardioSEAL® Septal Occlusion System with QwikLoad

NMT Medical, Inc.

Boston, MA

02210

Change in the manufacturing process to propose an alternate vendor for the device.

P000049/S014

5/21/04

CardioSEAL® Septal Occlusion System with QwikLoad

NMT Medical, Inc.

Boston, MA

02210

 Changes related to the implant fabric.  The proposed changes involve transferring the fabric heat set and fabric cut steps to an alternate vendor.

P010012/S027

5/14/04

CONTAK CD®, CONTAK CD 2, EASYTRAK®, CONTAK RENEWAL®, CONTAK RENEWAL 3

Guidant Corporation

St. Paul, MN

55112

Change in the aeration time used by Guidant’s alternate sterilization site.

P020009/S016

5/14/04

Express 2 Coronary Stent System

Boston Scientific

Maple Grove, MN

55311

Reduction in the sampling plan for destructive balloon burst testing.

P020023/S004

5/5/04

Restylane Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Addition of a 1 ml vial size for the Restylane Injectable Gel.

P020023/S005

5/10/04

Restylane Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Three changes in the manufacturing processes.

P020023/S006

5/10/04

Restylane Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Changes in increasing utilization for some of the manufacturing process equipment.

P030025/S003

5/14/04

Taxus Express 2 Coronary Stent System

Boston Scientific

Maple Grove, MN

55311

Reduction in the sampling plan for destructive balloon burst testing.