NaviStar™ DS and Celsius™ DS Diagnostic/Ablation Catheters, Stockert 70 Generator (model S7001 with software version 001/033) and Catheter Interface Cables

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for the NaviStar DS and Celsius DS Diagnostic/Ablation Catheters, Stockert 70 Generator and accessories.  The NaviStar DS and Celsius DS Catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and for use with the Stockert 70 (model S7001 with software version 001/033) for the treatment of Type I atrial flutter in patients age 18 or older.  The NaviStar DS Catheter provides location information when used with the Carto EP Navigation System.

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

Boston Scientific Scimed, Inc.

Maple Grove, MD

55311

Approval for the Express™ and Express2™ Monorail and Over-the-Wire Coronary Stent Systems.  These devices are indicated for improving coronary luminal diameter in the following:  1) Patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length < 18 mm) with a reference vessel diameter of 3.0 to 5.0 mm.  2) Treatment of abrupt or threatened abrupt closure (AC/TAC) in patients with failed interventional therapy in lesions in native coronary arteries of 2.25 to 5.0 mm (inclusive) in diameter and < 30 mm long.  Long-term outcome (beyond 6 months) for this permanent implant is unknown at present.

Abbott HAVAB EIA ASSAY

Abbott Laboratories

Abbott Park, IL

60064

Approval to add testing of a sensitivity panel to the dilution factor confirmation performed in the testing of the HAVAB Conjugate and to add additional testing of the HAVAB EIA Masterlot to provide a quality check of the final packaged kit.

Abbott HAVAB, HAVAB EIA, and IMx HAVAB ASSAYS

Abbott Laboratories

Abbott Park, IL

60064

Approval to add testing of a sensitivity panel for qualification of the Hepatitis A Virus extract used in the HAVAB assays to coat the solid phase of the bead and to tighten assay acceptance specification for HAV antigen qualification.

Abbott IMx HAVAB ASSAY

Abbott Laboratories

Abbott Park, IL

60064

Approval to add a quality control test which will be performed after the regent pack is packaged.

Stormer Balloon Dilatation Catheter with Zipper Delivery

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for the Stormer Balloon Dilatation Catheter with Zipper Delivery, which is indicated for balloon dilatation of the stenoic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Abbott HAVAB-M ASSAY

Abbott Laboratories

Abbott Park, IL

60064

Approval to add additional testing to the HAVAB-M EIA Masterlot to provide a quality check of the final packaged kit.

HAVAB-M, HAVAB-M EIA, and IMx HAVAB-M ASSAYS

Abbott Laboratories

Abbott Park, IL

60064

Approval to add testing of a sensitivity panel for qualification of the Hepatitis A Virus extract used in the HAVAB assays to coat the solid phase of the bead and to tighten assay acceptance specifications for HAV antigen qualification.

Abbott IMx HAVAB-M ASSAYS

Abbott Laboratories

Abbott Park, IL

60064

Approval to add a quality control test which will be performed after the reagent pack is packaged.

Drilac® Cubes and Granules

Kensey Nash Corporation

Exton, PA

19341

Approval for new manufacturing and sterilization sites.  The manufacturing site is located at Kensey Nash Corporation, Exton, Pennsylvania.  The new sterilization site is located at Steris Isomedix Services, Whippany, New Jersey.

Abbott IMx AFP

Abbott Laboratories

Abbott Park, IL

60064

Approval to add a quality control test which will be performed after the reagent pack is packaged.

Abbott AxSYM AFP

Abbott Laboratories

Abbott Park, IL

60064

Approval to add a quality control test which will be performed after the reagent pack is packaged.

FreshLook COLORBLEMDS® (phemfilcon A) UV Soft Contact Lenses

CIBA Vision Corporation

Duluth, GA

30097

Approval for a labeling modification of the secondary box carton to include the claim “improved Comfort”.

Itrel®3, Synergy™ and Synergy Versitrel™ Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Model 3890 Pisces Z Quad™ Lead, Model 3891 Pisces Z Quad Compact™ Lead, Model 3892 Pisces Z Quad Plus™ Lead and Model 3550-22 and 3550-23 lead revision kits.  The devices are indicated as an aid in the management of chronic, intractable Pain of the trunk or limbs.

Nucleus 22 Cochlear Implant System for Adults

Cochlear Americas

Englewood, CO

80112

Approval for proposed labeling changes as outlined in Attachment 3.

Abbott Anti-Delta (EIA)

Abbott Laboratories

Abbott Park, IL

60064

Approval for changes to the Abbott Anti-Delta (EIA) master lot testing.

Life Pulse High Frequency Ventilator Model 203

Bunnell, Inc.

Salt Lake City, UT

84115

Approval for a new patient box.

TDx/TDxFLx Cyclosporine and Metabolites Whole Blood

Abbott Laboratories

Abbott Park, IL

60064

Approval to place into effect the updated quality control test for evaluating sheep antiserum.

TDx/TDxFLx Cyclosporine and Metabolites Whole Blood and TDx/TDxFLx Cyclosporine Monoclonal Whole Blood

Abbott Laboratories

Abbott Park, IL

60064

Approval to add a quality control test which will be performed after the reagent pack is packaged.

Nucleus 22 Cochlear Implant System for Children

Cochlear Americas

Englewood, CO

80112

Approval for proposed labeling changes as outlined in Attachment 3.

Model 3000 Series of Implantable Pumps

Codman and Shurtleff, Inc.

Walpole, MA

02081

Approval for a change to the labeling to add a magnetic resonance imaging (MRI) compatibility statement.  One label is a MRI Data Chart and one label is a Technical Report describing the effects of MRI on the device.

Exogen 3000™ Low Intensity Fracture Healing System

Smith and Nephew, Inc.

Memphis, TN

38116

Approval for the following labeling changes: reformatting, inclusion of statements based on prior ODE requests, and additional information regarding error conditions that may occur during operation of the device.

Abbott IMx and AxSYM PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval to add a quality control test which will be performed after the reagent pack is packaged.

AIA-PACK PA

Tosoh Medics, Inc.

San Francisco, CA

94080

Approval to change the location of the manufacturing facility of the ascites fluid used in the preparation of the monoclonal antibodies from the Tosoh Tokyo Research Center in Ayase, Japan to Nisseiken, Co. Ltd. In Tokyo, Japan.

EPT-1000 Cardiac Ablation System

Boston Scientific Corporation

Natick, MA

01760

Approval for revised indications for use for the SteeroCath-T, Polaris-T, and Blazer II Ablation Catheters, which are components of the EPT-1000 Cardiac Ablation System.  The catheters are indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia.

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

B. Braun Medical, Inc.

Washington, D.C.

20004

Approval for  1) the transfer of the sterilization process for the blood tubing line component of B. Braun Medical, Inc.’s Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) System from its current, PMA approved location to the B. Braun Carex S.p.A. facility; and  2) the proposal to sterilize the blood tubing lines using 10 percent ethylene oxide (EtO) and 90 percent carbon dioxide (CO2).

CLARION® CII Bionic Ear, HiFocus Electrode without Positioner (Model AB-5100H-11A) and HiRes Software (Model CI-6055)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the commercial distribution of the CLARION HiFocus Electrode without the Positioner (Model AB-5100-11A) in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17-years, 11-months of age).  It also requested approval of the High Resolution Speech Processing Strategy (HiRes Software, Model Number CI-6055) for both patient populations.

BTE Firefly™, Model CI-5705 (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the BTE Firefly, Model CI-5705.  This device provides system verification capability to clinicians and parents including battery charge status, system lock status, and program slot information.

Clarion Multi-Strategy Cochlear Implant (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for changing the product name of the HiRes Software, Model Number CI-6055.  The software will be marketed under the trade name SoundWave Professional Suite, Model Number CI-6055, and is indicated for use in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12 months to 17 years, 11-months of age).

Livewire TC™ Cardiac Ablation System

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for revised indications for use for Livewire TC™ ablation catheters.  The catheters are indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.

CLARION® CII Bionic Ear, HiFocus Electrode without Positioner (Model AB-5100H-11A) and HiRes Software (Model CI-6055)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the commercial distribution of the CLARION HiFocus Electrode without the Positioner (Model AB-5100-11A) in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17-years, 11-months of age).  It also requested approval of the High Resolution Speech Processing Strategy (HiRes Software, Model Number CI-6055) for both patient populations.

BTE Firefly™, Model CI-5705 (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the BTE Firefly, Model CI-5705.  This device provides system verification capability to clinicians and parents including battery charge status, system lock status, and program slot information.

Clarion Multi-Strategy Cochlear Implant (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for changing the product name of the HiRes Software, Model Number CI-6055.  The software will be marketed under the trade name SoundWave Professional Suite, Model Number CI-6055, and is indicated for use in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12 months to 17 years, 11-months of age).

Medtronic® Interstim® Therapy for Urinary Control (Lead Models 3889 and 3093)

Medtronic, Inc.

Shoreview, MN

55216

Approval for Lead Models 3889 and 3093 for use with the Medtronic® Interstim® Therapy for Urinary Control, which is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Abbott IMx Tacrolimus II

Abbott Laboratories

Abbott Park, IL

60064

Approval for changes to the Abbott IMx Tacrolimus II master lot testing.

Abbott IMx Tacrolimus II

Abbott Laboratories

Abbott Park, IL

60064

Approval for the addition of testing of Model 1 Calibrator to verify the proper filling of the calibrator.

Urologix Targis™ System

Urologix, Inc.

Minneapolis, MN 55447

Approval for a change from the standard antenna (2.8 cm in length) to a shortened version (2.0 cm in length).  The device, as modified, will be marketed under the trade name Urologix Targis™ System, and is intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasmia (BPH), and is indicated for men with prostatic urethra lengths of 2.5 to 3.5 cm.

Multi-Link RX and OTW Zeta™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95054

Approval for the Multi-Link RX and OTW Zeta™ Coronary Stent Systems.  The devices are indicated for improving coronary lumen diameter in the following:  1) Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.  2) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length ≤ 35 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.  3) Restoring coronary  flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length ≤ mm with a reference vessel diameter of 2.5 mm to 4.0 mm.  4) Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (≤ 35 mm in length) with reference vessel diameters ranging from 2.5 mm to 4.0 mm.  Long-term outcome for this permanent implant is unknown at present.

S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV 2000 balloon, S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV100 balloon, S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV2000 balloon, and S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV100 balloon

Medtronic, AVE

Santa Rosa, CA

95403

Approval for the following expanded device indications:  The S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV 2000 balloon 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 ranting from 3.0 mm to 4.0 mm through direct stenting or predilatation.  Long-term outcome (beyond 180-days) for this permanent implant is unknown at present.”  The S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV100 balloon 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 through direct stenting or predilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.”  The S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV2000 balloon 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 through direct stenting predilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.  The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only.  The rapid exchange Stent Delivery System is not intended for use as a stand-alone PTCA perfusion catheter.” The S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV100 balloon is indicated for: “improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length ≤ mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm through direct stenting or predilatation.  Long-term outcome (beyond 180-days) for this permanent implant is unknown at present.  The rapid exchange Stent Delivery System is not intended for use as a stand-alone PTCA perfusion catheter.”

Nucleus 24 Cochlear Implant System

Cochlear Americas

Englewood, CO

80112

Approval for proposed labeling changes as outlined in Attachment 3.

ImageChecker M1000

R2 Technology, Inc.

Sunnyvale, CA

94087

Approval for a revision of the labeling for the device based on new analysis of the original PMA clinical data.

Continuous Glucose Monitoring System

Medtronic MiniMed

Northridge, CA

91325

Approval for a manufacturing site change and a design modification of the glucose sensor component of the Continuous Glucose Monitoring System.

Surgifoam Absorbable Gelatin Powder

Johnson & Johnson Wound Management

Somerville, NJ

08876

Approval for marketing a powdered form of the absorbable gelatin sponge.  The device, as modified, will be marketed under the trade name SURGIFOAM Absorbable Gelatin Powder (made from Absorbable Gelatin Sponge, USP) and is indicated for venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.

Hydroview IOL Blank Material

Bausch & Lomb Inc,

San Dimas, CA

91773

Approval for the transfer of the lens blank material manufacturing facility to Bausch & Lomb Inc., Wilmington, Massachusetts.

ANCURE® ENDOGRAFT® System

Guidant Corporation

Menlo Park, CA

94025

Approval for the transfer of the balloon catheter subassembly to Guidant Puerto Rico, Durado, Puerto Rico.

NAVISTAR™ Diagnostic/Ablation Deflectable Tip Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for an alternate manufacturing facility located at Biosense Webster, Inc., Chihuahua, Mexico.

Immuno 1® Complexed PSA (cPSA)

Bayer Corporation

Tarrytown, NY

10591

Approval for labeling changes.  The labeling changes include the revision of literature cited in the summary and explanation section and the addition of summary data from a new clinical study.  There is no change in the indication for use.

McGhan Saline-Filled Breast Implants

Inamed Corporation

Santa Barbara, CA

93111

Approval for revised labeling that reflects 5-year post-approval study data.

Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis.

Mentor Corporation

Santa Barbara, CA

93111

Approval for revised labeling that reflects 5-year post-approval study data.

Silicone Posterior Chamber Intraocular Lens, Model Z9000

Pharmacia and Upjohn Company

Pickerington, OH

43147

Approval for a new trade name for the Model Z9000 foldable posterior chamber intraocular lens, and other lens models which incorporate the modified prolate anterior optic surface.  The device, as modified, will be marketed under the trade name

Technis, with Z-sharp Optic Technology and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsifi-cation.  The lens is intended to be placed in the capsular bag.

BioEnterics LAP-BAND® Adjustable Gastric Banding System

Inamed Corporation

Santa Barbara, CA

93111

Approval for a design modification to the Lap-Band System’s Access Port with Tapered Connector.

Tachos DR Atrial Tx Implantable Cardioverter Defibrillator (ICD) System, Model 122499 with Software Cartridge SWM / I-KDR.0.C, Model 339684

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for the Tachos DR Atrial Tx Implantable Cardioverter Defibrillator (ICD) System, Model 122499 with Software Cartridge SWM / I-KDR.0.C, Model 339684.  The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  The device is indicated for use in ICD patients with either atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias.

Dimension® TPSA Flex® Reagent Cartridge

Dade Behring, Inc.

Newark, DE

19714

Approval for design changes.  The design changes include modification of the assay response to provide equivalent results for samples with varying mixtures of free PSA and PSA-ACT and optimization of the method design to minimize method response to human anti-murine immunoglobulin antibodies and human anti-bovine immunoglobulin antibodies.  The device, as modified, will be marketed under the trade name Dimension® TPSA Flex® Reagent Cartridge and is indicated for:  The TPSA method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (PSA) in human serum and plasma:  1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older.  Prostate biopsy is required for diagnosis of cancer  2) as an aid in the management (monitoring) of prostate cancer patients.

Fossa-Eminence & Condylar Prosthesis System and Fossa-Eminence Prosthesis System

TMJ Implants, Inc.

Golden, CO

80401

Approval for the “Surgeon’s Manual.”

Fossa-Eminence & Condylar Prosthesis System and Fossa-Eminence Prosthesis System

TMJ Implants, Inc.

Golden, CO

80401

Approval for the “Crystal Clear Anatomical Model Package Insert.”

Med-El COMBI 40+ Cochlear Implant System, Med-El Insertion Test Device (ITD)

Med-El Corporation

Durham, NC

27713

Approval for the modification to replace COMBI 40+ Cochlear Implant System “insertion Electrode” with the Insertion Test Device (ITD).  The device, as modified, will be marketed under the trade name Med-El Insertion Test Device and is indicated for individuals undergoing cochlear implant surgeries after a mastoidectomy, posterior tympanotomy, and cochleostomy have been performed and where access to the cochlea has been secured.

Fossa-Eminence & Condylar Prosthesis System and Fossa-Eminence Prosthesis System

TMJ Implants, Inc.

Golden, CO

80401

Approval for the “Surgeon’s Manual.”

Fossa-Eminence & Condylar Prosthesis System and Fossa-Eminence Prosthesis System

TMJ Implants, Inc.

Golden, CO

80401

Approval for the “Crystal Clear Anatomical Model Package Insert.”

GALILEO™ III Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for the GALILEO™ III Intravascular Radiotherapy System.  The device, as modified, will be marketed under the trade name GALILEO™ III Intravascular Radiotherapy System and is indicated as follows:  “The GALILEO™ III Intravascular Radiotherapy System is intended to deliver beta radiation to the site of successful percutaneous coronary intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions ≤ 47 mm in a reference vessel diameter 2.4 mm to 3.7 mm.”

Soundtec Direct IPCa

Soundtec, Inc.

Oklahoma City, OK

73112

Approval for the Soundtec Direct IPCa System.  The indications for use has not been changed.

Genesis Neurostimulation (IPG) System

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for the Model 3811 PainDoc Computerized Support System, Version 2.01 for use with the Genesis Model 3850 Patient Programmer which are indicated as an aid in the management of chronic intractable pain of the trunk  and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

QuickSeal Arterial Closure System with Q-Foam

Sub-Q, Inc.

San Clemente, CA

92673

Approval for a change in hemostatic material from Gelfoam to Q-Foam.

Abbott HAVAB, HAVAB EIA and IMx HAVAB

Abbott Laboratories

Abbott Park, IL

60064

Addition of a Manufacturers Working Cell Bank (MWCB) and limiting the number of cell passages that can be performed for antigen production using cells from the new MWCB.

Abbott HAVAB-M, HAVAB-M EIA and IMx HAVAB-M

Abbott Laboratories

Abbott Park, IL

60064

Addition of a Manufacturers Working Cell Bank (MWCB) and limiting the number of cell passages that can be performed for antigen production using cells from the new MWCB.

Rotablator Rotational Angioplasty System

Boston Scientific/SCIMED

Maple Grove, MN

55311

Change in the number of audit samples taken for destructive compression testing on the UV bond subassembly line.

GlucoWatch® G2™ Biographer

Cygnus, Inc.

Redwood City, CA

94063

Change in the manufacturing process to fully automate the AutoSensor assembly process.

Diagnostic Duett Sealing Device, Model 2200; Diagnostic Duett Pro Sealing Device, Model 2210; and D-Stat Flowable Hemostat, Model 4000

Vascular Solutions, Inc.

Minneapolis, MN

55441

Change in the endotoxin extraction procedure for testing the sealing and hemostasis devices.

Novoste™        Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Change in the manufacturing process of the Novoste™ Beta-Cath™ System Source Train Gold Markers which involves the removal of the electroless nickel flashing process.

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Herndon, VA

20171

Change in the site for bacterial endotoxin testing of certain components used in Deflux® Injectable Gel, intended for treatment of vesicoureteral reflux in children.