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PMA Final Decisions Rendered for August 2001

P000025

8/20/01

MED-EL COMBI 40+ Cochlear Implant System

Med-El Corporation

Durham, NC

27713

Approval for the MED-EL COMBI 40+ Cochlear Implant System (COMBI 40+). The device is intended to provide the opportunity to detect and recognize auditory information through electrical stimulation of the auditory nerve for server to profoundly hearing-impaired individuals who obtain little or no benefit from conventional acoustic amplification in the best-aided condition. The COMBI 40+ is indicated for the following patient populations: Adults of eighteen (18) years of age or older who have bilateral, sensorineural hearing impairment and obtain limited benefit from appropriately fitted binaural hearing aids. These individuals typically demonstrate bilateral severe to profound sensorineural hearing loss determined by a pure tone average of 70 dB or greater at 500 Hz, 1000 Hz, and 2000 Hz. Limited benefit from amplification is defined by test scores of 40% correct or less in best-aided listening condition on CD recorded tests of open-set sentence recognition Hearing In Noise Test (HINT) sentences. Children aged eighteen (18) months to seventeen (17) years eleven (11) months must demonstrate a profound, bilateral sensorineural hearing loss with thresholds of 90 dB or greater at 1000Hz. In younger children, little or no benefit is defined by lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three (3) to six (6) month period. In older children, lack of aided benefit is defined as < 20% correct on the Multi-syllabic Lexical Neighborhood Test (MLNT) or Lexical Neighborhood Test (LNT), depending upon the child’s cognitive ability and linguistic skills. A three (3) to six (6) month hearing aid trial is required for children without previous experience with hearing aids. Radiological evidence of cochlear ossification may justify a shorter trial with amplification.

8/28/01

Medtronic® InSync® Biventricular Pacing System including the Model 8040 InSync® Pulse Generator, the Model 9980 Programmer Software, and the Attain™ LV Model 2187 and Attain™ CS Model 2188 Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® InSync® Biventricular Pacing System including the Model 8040 InSync® Pulse Generator, the Model 9980 Programmer Software, and the Attain™ LV Model 2187 and Attain™ CS Model 2188 Leads. The pulse generator and leads are indicated as follows: 1) The InSync Model 8040 pulse generator is indicated for the 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, and have a left ventricular ejection fraction ≤ 35% and a QRS duration ≥ 130 ms. 2) The Attain LV Model 2187 lead has application as part of a Medtronic biventricular pacing system. 3) The Attain CS Model 2188 lead has application where permanent atrial, or dual-chamber pacing systems are indicated, or as part of a Medtronic biventricular pacing system.

8/31/01

OrCel™ (Bilayered Cellular Matrix)

Ortec International, Inc.

New York, New York

10032

Approval for the OrCel™ Bilayered Cellular Matrix. The device is indicated for the treatment of fresh, clean split thickness donor site wounds in burn patients.

8/30/01

Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Vitros Immunodiagnostic Products Anti-HCV Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Approval for the Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Vitros Immunodiagnostic Products Anti-HCV Calibrator. These devices are indicated for: The Vitros Immunodiagnostic Products Anti-HCV Reagent Pack is indicated for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C Virus (anti-HCV) in human serum and plasma (heparin, EDTA and sodium citrate) using the Vitros ECi Immunodiagnostic System. Three recombinant hepatitis C virus encoded antigens are used. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis C virus (state or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. The Vitros Immunodiagnostic Products Anti-HCV Calibrator is indicated for use in the calibration of the Vitros ECi Immunodiagnostic System for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA and sodium citrate) using Vitros Anti-HCV Reagent Packs. The Vitros Anti-HCV Calibrator has been validated for use only on the Vitros ECi Immunodiagnostic System with the Vitros Immunodiagnostic Products Anti-HCV Reagent Pack.

180-Day

Hydrocurve 3 Toric (Bufilcon A) Extended Wear Soft (Hydrophilic) Contact Lenses

CIBA Vision Corporation

Duluth, GA

30097

Approval for the manufacturing facility located at CIBA Vision (formerly Wesley Jessen), Cidra, Puerto Rico.

Real-Time

Percutaneous Coronary Dilatation Catheters

Guidant Corporation

Temecula, CA

92589

Approval for modifications in the Instructions For Use books of the POWERSAIL™, HIGHSAIL™, CROSSSAIL™, OPENSAIL™, ACS OTW PHOTON™, ACS RX GEMINI™, AND ACS TX ESPRIT PTCA catheters.

180-Day

Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Implantable Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change in the indications for use from "…chronic intractable pain of the trunk or limbs…" to "…chronic intractable pain of the trunk and/or limbs…". The indication statement has been revised to state "The Medtronic [trade name] System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia."

180-Day

Itrel and Synergy Spinal Cord Stimulation Systems

Medtronic, Inc.

Minneapolis, MN

55421

Approval for an alternate manufacturing facility for the Model 7495 and Model 7495LZ Extensions. The facility is located at Medtronic Neurological Puerto Rico Operations, Villalba, Puerto Rico.

Special

Medtronic Model 7424 Itrel® II, Model 7425 Itrel® III, and Model 7427 Synergy Spinal Cord Stimulation Systems

Medtronic, Inc.

Minneapolis, MN

55421

Approval for an additional quality control step to verify that the neurostimulators are manufactured to their specification, i.e., that the neurostimulator has the specified insulation between the battery and the internal surface of the titanium (case) shield.

Special

Medtronic SynchroMed® Infusion System

Medtronic Inc.

Minneapolis, MN

55432

Approval for additional labeling for pump replacement procedures.

Special

Scimed PTCA Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a labeling change that strengthens a warning statement included in the directions for use manual. Specifically, the labeling statement is being modified to expand the information provided regarding the affect of re-processing or re-sterilization. The change applies to all Directions for Use manuals of currently marketed PTCA Catheters approved under this PMA.

Real-Time

Integra® Dermal Regeneration Template

Integra Life Sciences Corp.

Plainsboro, NJ

08536

Approval for an update of the device labeling to incorporate the results of the post approval study.

Real-Time

Integra® Dermal Regeneration Template

Integra Life Sciences Corp.

Plainsboro, NJ

08536

Approval for minor changes to the device labeling.

Special

Rotablator Rotational Angioplasty System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a change in the Warning statement in the Instructions for Use Manual.

180-Day

VasoSeal ES Device

Datascope Corporation

Mahwah, NJ

07430

Approval to modify the IFU for the VasoSeal ES device to include angiography data.

Special

Boston Scientific Scimed TIPS WALLSTENT System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a change to a Warning statement in the Instructions for Use Manual.

180-Day

Angio-Seal Vascular Closure Device STS Platform

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for adding the Locking Cap feature onto the delivery system of the Angio-Seal Vascular Closure Device with Self-Tightening Slipknot (STS). The device, as modified, will be marketed under the trade name Angio-Seal Vascular Closure Device STS Platform and is indicated for closing and reducing the time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiographic procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8F Angio-Seal device and a 6 French or smaller procedural sheath for the 6F Angio-Seal device.

Special

Natural-Knee® & Natural-Knee® II

Sulzer Orthopedics, Inc.

Austin, TX

78717

Approval for changes in the manufacturing process to further assure the cleanliness of the devices.

Special

Iliac Wallstent™ System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a change in the Warning statement in the Instructions for Use Manual.

180-Day

Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test

Gen-Probe, Inc.

San Diego, CA

92121

Approval for changes to the package insert in lieu of a post-marketing study. The changes include addition of interpretive criteria from the Center for Disease Control and Prevention’s July 7, 2000, MMWR "Update: Nucleic Acid Amplification Tests for Tuberculosis" and the change of a precaution statement concerning negative test results to a warning statement. Theses changes will be provided in a technical bulletin that will accompany the package insert for the next 4-6 months until the next printing of the package insert.

180-Day

ACS: 180 and ADVIA Centaur PSA Immunoassays

Bayer Corp.

Medfield, MA

02052

Approval for processing and final packaging at Bayer Diagnostics, Walpole, Massachusetts.

Real-Time

Apligraf (Graftskin)

Organogenesis, Inc.

Canton, MA

02021

Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 700).

180-Day

ThinPrep® 2000 System

Cytyc Corp.

Boxborough, MA

01719

Approval to include in the current package insert, data and information from a direct-to-vial clinical study for High Grade Squamous Intraepithelial and more severe lesions.

180-Day

TransCyte® Human Fibroblast Derived Temporary Skin Substitute

Advanced Tissue Sciences

LaJolla, CA

92037

Approval for amended labeling to include information regarding the results of testing the donor mother’s sera for viruses and other infectious agents.

180-Day

Activa Tremor Control Therapy System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for an alternate manufacturing facility for the Model 7495 Extension. The facility is located at Medtronic Neurological Puerto Rico Operations, Villalba, Puerto Rico.

Special

Medtronic Active® Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the addition of an additional quality control process step to verify that neurostimulators are manufactured to their specification, e.g., the neurostimulator has the specified insulation between the battery and the internal surface of the titanium case (shield).

Real-Time

Closer/Closer S Percutaneous Vascular Surgery Devices

Perclose, Inc.

Redwood City, CA

94063

Approval for a manufacturing and specification change to the Knot Pusher with Trimmer (Suture Trimmer) Hook accessory.

180-Day

Medtronic® Interstim® Therapy for Urinary Control (Model 3031A Patient Programmer)

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Model 3031A Patient Programmer for use with the Medtronic® Interstim® Therapy for Urinary Control, which 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.

180-Day

Medtronic® Interstim® Therapy for Urinary Control (Model 3550-03 Twist-Lock Screening Cable and Model 3550-05 Percutaneous Extension and Tunneling Tool Kit for temporary Sacral Nerve Stimulation as part of a Staged Implant Technique)

Medtronic, Inc,

Minneapolis, MN

55421

Approval for the Model 3550-03 Twist-Lock Screening Cable and Model 3550-05 Percutaneous Extension and Tunneling Tool Kit for temporary sacral nerve stimulation as part of a staged implant technique for the Medtronic® Interstim® Therapy for Urinary Control, which 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.

Special

AMS 700 Series Product Line Inflatable Penile Prostheses

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for modification of the postapproval study requirements stated in the November 2, 1998 letter to reduce the maximum follow-up duration from 10 to 5 years post-implantation.

Special

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

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for additional quality assurance steps to ensure product traceability during the InhibiZone™ surface treatment process.

180-Day

Nucleus 24 Cochlear Implant System

Cochlear Corp.

Englewood, CO

80112

Approval for Software version R126.

Special

RADIUS™ Coronary Stent with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a change in the Warning statement in the Instructions for Use Manual.

Special

NIR™ Coronary Stent with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a change in the Warning statement in the Instructions for Use Manual.

180-Day

Boston Scientific/Scimed Magic WALLSTENT® Endoprosthesis with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate manufacturing facility located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland.

180-Day

Boston Scientific/Scimed Magic WALLSTENT® Endoprosthesis with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate manufacturing facility located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland.

Special

Boston Scientific Scimed Magic WALLSTENT® Endoprosthesis with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for a change in the Warning statement in the Instructions for Use Manual.

Special

Sharpx Needle Destruction Unit

Biomedical Disposal, Inc.

Norcross, GA

30092

Approval for labeling changes reducing 15 page instruction booklet to a summary sheet.

180-Day

Medtronic Sigma and Medtronic 350 Series Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for alternate manufacturing, packaging and sterilization facilities at Medtronic BV, The Netherlands and Medtronic Europe S.A., Tolochenaz, Switzerland.

180-Day

Medtronic Model 7250 Implantable Cardioverter Defibrillator System (AF only study)

Medtronic, Inc.

Shoreview, MN

55126

Approval for the post-approval protocol for continued follow-up of the patients who received the Model 7250 for the AF only indication.

Real-Time

FloSeal Matrix®/Proceed® Hemostatic Sealants (Dry Form)

Fusion Medical Technologies, Inc.

Fremont, CA

94555

Approval for an increase in an intermediate specification for residual glutaraldehyde from 20 to 40 ppm, the removal of the neurosurgical exclusion from the indications statement and the addition of the nasal/sinus instructions and information to the labeling of the "Dry" form of the Fusion Matrix product.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for changing plastic machined components to injection-molded components for delivery catheter handle and contralateral cutter.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for changes to delivery catheter ipsilateral capsule and contralateral pullwire.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for labeling changes, including use of stents and guidewires, and jacket retraction technique.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for changes to manufacturing process (addition of new in-process quality checks, quantification of inspection criteria, removal of redundant wire inspection, definition of testing requirements for new lots of Elgiloy wire, dimensional changes, and addition of requirements for conducting corrosion fatigue testing).

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for changes to design and manufacturing to address inferior release wire getting stuck or breaking in the Ancure tube devices during wire retraction.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for labeling and manufacturing changes.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for modifications related to force required to retract delivery catheter jacket.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for modifications related to the contralateral torque catheter.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for modifications (20 manufacturing process changes and one design change) related to the delivery catheter.

180-Day

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corp.

Menlo Park, CA

94025

Approval for three month shelf life based on changes to packaging.

Real-Time

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for modifications to the labeling for the GlucoWatch® Automatic Glucose Biographer.

180-Day

PepGen P-15 Flow (Formerly PepGen P-15 Putty)

CeraMed Corporation

Lakewood, CO

80228

Approval for a modification to PepGen P-15 to form PepGen P-15 Putty. The device, as modified, will be marketed under the trade name PepGen P-15 Flow, but have the same indications for use as PepGen P-15.

Real-Time

WavSTAT™ Optical Biopsy System

SpectraScience, Inc.

Minneapolis, MN

55447

Approval for a change in the trade name of the device and related accessories to add the word "WavSTAT™" to the beginning of the trade name. The device, as modified, will be marketed under the trade name "WavSTAT™ Optical Biopsy System." The device is indicated for use as an adjunct to lower gastrointestinal (GI) endoscopy. The device is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove. The device is only to be used in deciding whether such polyps should be removed (which includes submission for histological examination).

180-Day

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

Mentor Corp.

Santa Barbara, CA

93111

Approval for LAL testing to be done on a skip lot audit basis every six months.

135-Day

Vitro Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostic, Inc.

Rochester, NY

14626

Approval to change the test release limits applied to the output of that model for the Vitros Anti-HBs assay.

180-Day

Nucleus 24 Auditory Brainstem Implant System

Cochlear Corp.

Englewood, CO

80112

Approval for Software version R126.

Real-Time

Novoste™ Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for modifications to the design of the proximal marker of the Source Train.

135-Day

Novoste™ Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for an alternate method of receipt and assembling of source trains.

Real-Time

Bard Stinger™ Ablation Catheter

C.R. Bard, Inc.

Lowell, MA

01851

Approval for an additional "G" curve configuration and additional length of 85 centimeters for the Stinger, Stinger M, and Stinger S ablation catheters.

8/28/01

PROSORBA® Column

Fresenius HemoCare, Inc.

Redmond, WA

98052

Elimination of the shaking step from the manufacturing process.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/7/01

Perfluoron® (purified perfluoro-n-octane liquid)

Alcon Laboratories, Inc.

Fort Worth, TX

76134

Elimination of finished product intravitreal testing for Perfluoron® and revision of the "Purified Perfluoro-n-Octane Analytical Test Monograph" regarding calculation of impurities. The specification of ≥ 99.9% for Purified Perfluoro-n-Octane remains unchanged.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/14/01

MULTI-LINK Family of Coronary Stent Systems

Guidant Corp.

Temecula, CA

92591

Change in the pyrogen sampling plan for the MULTI-LINK Family of Coronary Stent Systems.

8/21/01

NIR™ Premounted Stent System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change in the cleaning process for the stent.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/8/01

Medtronic Pacing Leads

Medtronic, Inc.

Minneapolis, MN

55432

Change in the supplier of polyetherurethane.

8/3/01

Gluco Watch Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Change in manufacturing methods and procedures to upgrade from a manual process at Cygnus, Inc. to an expanded automated process at Corium Manufacturing Group.

8/8/01

Saline-Filled Breast Implants

McGhan Medical Corp.

Santa Barbara, CA

93111

Change in manufacturing method. The change adds an alternative method for a casting process using the molding method of the Style 68 saline-Filled breast implant shell component used in the fabrication of saline-filled breast implants. There will be no changes to component specifications, designed performance specifications of the finished device, or to the PMA designated physical and chemical specifications of the finished device.