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PMA Final Decisions Rendered for February 2000 |
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A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
P980040 2/3/000 |
AMOÒ SENSARÔ Soft Acrylic, UV Light-Absorbing, Posterior Chamber Intraocular Lens (IOL), Model AR40 |
Allergan, Inc. Irvine, CA 92612-9534 |
Approval for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by extracapsular cataract extraction. |
2/24/2000 |
CellugelÒ Ophthalmic Viscosurgical Device (OVD) |
Alcon Laboratories Fort Worth, Texas 76134 |
Approval for use during surgery in the anterior segment of the eye. It is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues and to manipulate tissues during surgery. It may also be used to coat intraocular lenses and other instruments during cataract extraction and IOL insertion. |
2/23/2000 |
TECHNOLASÒ 217A Excimer Laser System |
Bausch & Lomb Surgical Irvine, California 92618 |
Approval to perform Laser In-Situ Keratomileusis (LASIK): in treatments for the reduction or elimination of myopia (nearsightedness) from �00 to �00 diopters D with less than �00 D astigmatism; in patients with documented stability of refraction for the prior 12 months as demonstrated by a change in manifest refraction of less than or equal to 0.5 D (in both cylinder and sphere components); and in patients 21 years of age or older. |
PMA Supplemental Approvals | |||
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
N16837/S3 2/11/2000 |
Artegraft Bovine Heterograft |
Artegraft, Inc. |
Approval for a manufacturing site located at Artegraft, Inc., 220 North Center Drive, North Brunswick, NJ. |
*N17600/S16 2/28/2000 |
AviteneÔ Microfibrillar Collagen Hemostat (MCH) |
Davol, Inc. Subsidiary of C.R. Bard, Inc. Woburn, Massachusetts 01801 |
Approval to market a product line extension, i.e., Avitene UltraFoam Microfibrillar Collagen Hemostat (MCH) Sponge. |
N50510/S112 2/1/2000 |
Vitekâ 2 Gram Negative Susceptibility Test for Ticarcillin |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic ticarcillin at concentrations of 16, 32 and 64 m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organism to ticarcillin in the range of <8 to >128m g/ml. |
N50510/S113 2/8/2000 |
Vitekâ 2 Gram Positive Susceptibility Test for High-Level Streptomycin |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic streptomycin at a concentration of 1000 m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System. |
N50510/S114 2/7/2000 |
Vitekâ 2 Gram Negative Susceptibility Test for Norfloxacin |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic norfloxacin at concentrations of 1, 8 and 32m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organism to norfloxacin in the range of <0.5 to >16m g/ml. |
N50510/S115 2/8/2000 |
Vitekâ 2 Gram Negative Susceptibility Test for Tetracycline |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic tetracycline at concentrations of 2, 4, and 8m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to tetracycline in the range of <1 to >16m g/ml. |
N50510/S116 2/8/2000 |
Vitekâ 2 Gram Positive Susceptibility Test for Nitrofurantoin |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32 and 64 m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organisms to nitrofurantoin in the range of <16 to >512m g/ml. |
N50510/S117 2/15/2000 |
Vitekâ 2 Gram Positive Susceptibility Test for Oxacillin |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic oxacillin at concentrations of 0.5, 1 and 2m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organisms to oxacillin in the range of <0.25 to >4m g/ml. |
N50510/S118 2/10/2000 |
Vitekâ 2 Gram Negative Susceptibility Test for Cefoxitin |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic cefoxitin at concentrations of 8, 16, and 32m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organisms to cefoxitin in the range of <4 to >64m g/ml. |
N50510/S119 2/17/2000 |
Vitekâ 2 Gram Negative Susceptibility Test for Piperacillin/ Tazobactam |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic piperacillin/ tazobactam at concentrations of 4/4, 16/4, and 128/4m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organisms to piperacillin/ taxobactam in the range of <4/4 to >128/4m g/ml. |
N50510/S120 2/17/2000 |
Vitekâ 2 Gram Negative Susceptibility Test for Cefpodoxime |
bioMerieux, Inc. Hazelwood, MO 63042-2320 |
Approval for the addition of the antibiotic cefpodoxime at concentrations of 0.5, 1, and 4 m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek â 2 and is indicated for use in VitekÒ 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative organisms to cefpodoxime in the range of <0.25 to >8m g/ml. |
P810002/S050 2/28/2000 |
St. Jude Medical Mechanical Heart Valve |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval which describes a validation for a sterilization change. |
*P810046/S200 2/16/2000 |
ACS RX Solaris and ACS OTW Solaris Coronary Dilatation Catheters |
Vascular Intervention Group Temecula, CA 92589-9018 |
Approval for a revision to the Instructions for Use booklet for ACS RX SOLARISÔ and ACS OTW SOLARISÔ Coronary Dilatation Catheters to include the addition of the ACS Multi-Link TristarÔ Stent to sections pertaining to post-implant stent dilatation. |
*P830060/S47 2/23/2000 |
VENTAKÒ Implantable Cardioverter Defibrillator System ENDOTAKÒ Transvenous Defibrillation Lead System, ThinLineÔ and FINELINE Transvenous Endocardial Pacing Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for: a) all previously marketed Intermedics stylets kits to be marketed under new Guidant model numbers 6032-6066, 6765-6770, 6826, 6828, 6963, 6964, 6971, 6972, 6983, and 6985, and b) an alternate stylet kit package insert. These devices are indicated for aiding in the introduction of pacing and defibrillator leads. |
P850048/S16 2/24/2000 |
Access Hybritech PSA Assay |
Beckman Coulter, Inc. Chaska, Minnesota 55318 |
Approval for addition of the Access Hybritech PSA Assay on the Access Immunoassay analyzer to other approved instrument platforms. The AccessÒ HybritechÒ PSA assay is a paramagnetic particle, chemiluminiscent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum, using the Access Immunoassay Systems. 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 in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer. |
P860019/S156 2/1/2000 |
MAXXUMÔ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for an additional indication for the MAXXUMÔ PTCA Catheter(balloon diameters ranging from 2.5-4.0 mm in 0.25mm increments with balloon lengths of 13, 20 and 29 mm), the post-delivery expansion of balloon expandable stents. |
P860019/S158 2/23/2000 |
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters |
Boston Scientific/SCIMED Maple Grove, MN 5311-1566 |
Approval for use of an alternative catheter packaging configuration. |
*P870015/S35 2/25/2000 |
Medstone STS-T Lithotripter |
Medstone International, Inc. Aliso Viejo, California 92656 |
Approval for 1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and 2) the addition of protective covers for the U-arms� electrical connections. |
2/22/2000 |
Exogen 2000Ò or Sonic Accelerated Fracture Healing System (SAFHSÒ ) |
Exogen, Inc. Piscataway, New Jersey 08855 |
Approval for the non-invasive treatment of established nonunions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. |
P 900043/S17 2/1/2000 |
PALMAZ-SCHATZÔ MiniCrown Balloon-Expandable Stent with HepacoatÔ on DynastyÔ Over the Wire Delivery System |
Cordis Corporation Warren, NJ 07059 |
Approval for the addition of a heparin coating on the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent on DynastyÔ Over the Wire Delivery System. |
P900043/S18 2/25/2000 |
CrossFlexÔ LC Balloon Expandable Stent with Over-the-Wire Delivery System |
Cordis Corporation Warren, NJ 07059 |
Approval for a 5-year post-approval study protocol for the CrossFlexÔ LC Balloon Expandable Stent with Over-the-Wire Delivery System. |
P900043/S21 2/4/2000 |
PALMAZ-SCHATZÔ Crown Balloon Expandable Stend with PowerGripÔ Over-the-Wire Delivery System |
Cordis Corp. Warren, NJ 07059 |
Approval for 1)the addition of a note in the Instructions for Use regarding correct prepping procedures for the balloon, 2)the addition of new width and height specifications for the inflation lumen tubing, and 3) the addition of an automated deflation test prior to product release. |
P900056/S34 2/16/2000 |
RotablatorÒ Rotational Angioplasty System |
Boston Scientific Corporated Northwest Technology Center, Inc. Redmond, WA 98052-3376 |
Approval for the addition of a ground test to the calibration and final test procedure for the RotablatorÒ console. |
*P910073/S30 2/23/2000 |
VENTAKÒ Implantable Cardioverter Defibrillator System ENDOTAKÒ Transvenous Defibrillation Lead System, ThinLineÔ and FINELINE Transvenous Endocardial Pacing Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for: a) all previously marketed Intermedics stylets kits to be marketed under new Guidant model numbers 6032-6066, 6765-6770, 6826, 6828, 6963, 6964, 6971, 6972, 6983, and 6985, and b) an alternate stylet kit package insert. These devices are indicated for aiding in the introduction of pacing and defibrillator leads |
P920023/S10 2/14/2000 |
UroLumeÒ Endoprosthesis |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval to extend the shelf life expiration dating up to 5 years. |
*P920023/S11 2/9/2000 |
AMS UroLumeÒ Endoprosthesis for Recurrent Bulbar Urethral Strictures, Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy, and Detrusor External Sphincter Dyssynergia |
American Medical Systems Minnetonka, Minnesota 55343 |
Approval for modification of the delivery tool handle. |
P920032/S5 2/2/2000 |
Micro-PaceÔ Dual-Chamber Pulse Generator, Model 4553 |
Pace Medical, Inc. Waltham, Massachusetts 02154 |
Approval for an alternate vendor located at Princeton Technology, Inc., 12 Park Avenue, Hudson, New Hampshire 03051. |
P930034/S15 2/3/2000 |
SVS Apex PlusÒ Excimer Laser Workstation |
Summit Technology, Inc. Waltham, MA 02154 |
Approval of name change. The device, as modified, will be marketed under the trade name Infinity LSÔ Excimer Laser System. |
P940022/S13 2/2/2000 |
CLARIONÒ Multi-Strategy Cochlear Implant (Adult) |
Advanced Bionics Corp. Sylmar, CA 91342 |
Approval for the size reduction in the speech processor known as the Platinum Sound Processor. |
*P940031/S22 2/25/2000 |
Model 6698 Patient Test Magnet |
Guidant, Cardiac Rhythm Management St. Paul, MN 55112-5798 |
Approval for the Model 6698 Patient Test Magnet. |
P950005/S6 2/1/2000 |
CelsiusÔ Diagnostic/Ablation Deflectable Braided Tip Catheter Interface Autoclavable Cables (Models D-1170-01 and D-1170-05) |
Cordis Webster, Inc. Diamond Bar, CA 91765 |
Approval for autoclavable interface cables for use with the CelsiusÔ Diagnostic/Ablation Deflectable Braided Tip Catheters. |
*P960004/S11 2/23/2000 |
VENTAKÒ Implantable Cardioverter Defibrillator System ENDOTAKÒ Transvenous Defibrillation Lead System, ThinLineÔ and FINELINE Transvenous Endocardial Pacing Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for: a) all previously marketed Intermedics stylets kits to be marketed under new Guidant model numbers 6032-6066, 6765-6770, 6826, 6828, 6963, 6964, 6971, 6972, 6983, and 6985, and b) an alternate stylet kit package insert. These devices are indicated for aiding in the introduction of pacing and defibrillator leads |
*P960034/S1 2/7/2000 |
Heparin Surface Modified (HSM) Polymethylmethacry-late (PMMA) Posterior Chamber Intraocular Lenses |
Pharmacia & Upjohn Company Pickerington, OH 43147 |
Approval to manufacture the HSM PMMA posterior chamber intraocular lenses using UVEX 326 PMMA. |
P960058/S12 2/2/2000 |
CLARIONÒ Multi-Strategy Cochlear Implant (Pediatric) |
Advanced Bionics Corp. Sylmar, CA 91342 |
Approval for the size reduction in the speech processor known as the Platinum Sound Processor. |
*P970003/S25 2/16/2000 |
NeuroCybernetic Prosthesis (NCPÒ ) System |
Cyberonics, Inc. Houston, TX 77058 |
Approval for changes to the approved patient labeling for the NCP System. |
*P970004/S7 2/29/2000 |
MedtronicÒ InterstimÒ System for Urinary Control |
Medtronic, Inc. Minneapolis, MN 55421 |
Approval for a quick guide to the Model 3031 Patient Programmer that will be provided to implanting physicians for distribution to both currently implanted and future patients. |
P970031/S8 2/23/2000 |
Medtronic FreestyleÒ Aortic Root Bioprosthesis, Model 995 |
Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for a pre-trimmed subcoronary configuration, Model 995CS. |
P970038/S4 2/24/2000 |
Access Hybritech free PSA assay |
Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of the Access Hybritech free PSA on the Access Immunoassay analyzer to other approved instrument platforms. The device, as modified, will be marketed under the trade name Access Hybritech free PSA assay and is indicated for use as follows: The AccessÒ HybritechÒ free PSA is a paramagnetic particle, chemiluminiscent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA, as measuered by the Hybritech assays, is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer. |
P970061/S8 2/11/2000 |
RADIUSÔ Coronary Stent with Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311-1566 |
Approval for the addition of two tensile strength specifications for the pullwire assembly. |
*P990004/S002 2/8/2000 |
SURGIFOAMÒ Absorbable Gelatin Sponge, USP |
Ethicon, Inc. Somerville, New Jersey 08876-0151 |
Approval for a change in the "Indications for Use" statement. This changed requested the removal of neurosurgery form the exclusions. |
30-Day Notices (***135 Day Supplement was not required) | |||
APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
***N17511/S13 2/9/2000 |
HyskonÒ Hysteroscopy Fluid |
CooperSurgical, Inc. Huntington, CT 06484 |
Requested provision for the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility. |
***P830045/S68 2/18/2000 |
Bradycardia Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Requested the elimination of in-process x-ray imaging for all bradycardia pulse generators. |
***P860022/S52 2/4/00 |
Boston Equalens (Itafluoprofocon A) and Equalens II (Oprifocon A) Rigid Gas Permeable Contact Lens |
Polymer Technology Rochester, NY 14692 |
Approval for addition of one finishing laboratory, Procornea Nederland BV, Kollergan 9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distribution site for the referenced devices. |
***P880086/S69 2/18/2000 |
Bradycardia Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Requested the elimination of in-process x-ray imaging for all bradycardia pulse generators. |
***P900056/S35 2/11/2000 |
Rotoblator Rotational Angioplasty System |
Boston Scientific Corp. Redmond, WA 98052-1600 |
Requested the addition of an inspection of the advancer short drive shaft following the wet test. |
***P900070/S26 3/18/2000 |
Bradycardia Pulse Generators |
St. Jude Medical Sylmar, CA 91342 |
Requested the elimination of in-process x-ray imaging for all bradycardia pulse generators. |
***P980001/S16 2/25/2000 |
NIRÔ Premounted Stent Systems |
Boston Scientific Corporation A285 Maple Grove, Minnesota 55311 |
Requested a change to increase the tolerance allowed in the stent overlap to markerband placement by 0.25mm (from 0.25 mm to 0.50mm). |
***P990020/S2 2//8/2000 |
The AneuRxÔ Stent Graft System |
Medtronic AVE Peripheral Technologies Santa Rosa, CA 95407 |
Requested changes to eliminate a final cleaning step and to add a supplier of Nitinol tubing and as-cut stents. |
***P990020/S3 2//8/2000 |
The AneuRxÔ Stent Graft System |
Medtronic AVE Peripheral Technologies Santa Rosa, CA 95407 |
Requested changes to eliminate a final cleaning step and to add a supplier of Nitinol tubing and as-cut stents. |
*Real-Time Supplement
**135 Day Supplement
# "Special � Changes Being Effected"
# Panel-Track Supplement
Summary of PMA Originals & Supplements Approved
Originals: 3Summary of PMA Originals Under Review
Total Under Review: 105Summary of PMA Supplements Under Review
Total Under Review: 210Summary of All PMA Submissions Received
Originals: 5Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 41Filing to Approval:
FDA Time 108.1 Days
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