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PMA Final Decisions Rendered for August 1999 |
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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.
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|
8/6/99 |
Biotrin Parvovirus B19 IgG Enzyme Immunoassay |
Biotrin International, Limited |
This device is indicated for: The Biotrin Parvovirus B19 IgG Enzyme Immunoassay is intended for the qualitative detection of IgG antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, EDTA, and citrated plasma. This test, in conjunction w/the Biotrin Parvovirus B19 IgM Enzyme Immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with B19V. The results of these assays may be used to make a serological determination of past, recent, or current infection with B19V. The clinician should consider the results of these assays as presumptive for risk of fetal infection with B19V. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum). |
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8/6/99 |
BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) |
Biotrin, International, LTD. IRELAND |
The device is intended for the qualitative detection if IgM antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, EDTA, and citrated plasma. This test, in conjunction with the Biotrin Parvovirus B19 IgG Enzyme Immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with B19V. The results of these assays may be used to make a serological determination of past, recent, or current infection with B19V. The clinician should consider the results of these assays as presumptive for risk of fetal infection with B19V. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum). |
PMA SUPPLEMENTAL APPROVALS | |||
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APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|
N17987/S026 8/30/99 |
CSI (Crofilcon A) Extended Wear Soft Contact Lens (spherical 13.8 mm diameter) |
Wesley Jessen Corporation Des Plaines, IL 60018-5903 |
Approval to transfer manufacturing of the CSI lens to the manufacturing site located at Wesley Jessen, Inc., Route 173, El Jibaro Industrial Park, Cidra, Puerto Rico. |
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P820076/S022 8/24/99 |
Gemnos, Gemnos 04, Gemnos 04A, Gemnos TC04, and Dromos SL |
BIOTRONIK, Inc. Lake Oswego, OR |
Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS. |
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P830055/S063* 8/5/99 |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988 |
Approval to allow DePuy the option of manufacturing the LCS Rotating Platform Tibial Inserts, Meniscal Bearing Tibial Inserts and All Polyethylene Tibial Components from Ultra High Molecular Weight Polyethylene (UHMWPE) that is vacuum packaged in foil barrier bags and gamma sterilized (the GVF process). |
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P850089/S042* 8/11/99 |
Medtronic® CapSure SP Novus Model 5092 Pacing Lead and Vitatron Excellence SS+ Model IML 49B Pacing Lead |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for a tine design change for Model 5092 and IML 49B leads. |
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P860003/S031 8/10/99 |
UVAR® XTS™ Photopheresis System |
THERAKOS Exton, PA 19341 |
Approval for engineering changes to the UVAR® Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) | Modifying the Photoceptor® photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software.The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy. |
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P880091/S016 8/31/99 |
ELASTIMIDE® Ultraviolet-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens, Model AQ-5010V |
STAAR Surgical Company Monrovia, CA 91016 |
Approval for lens Model AQ-5010V in the power range of -4.0 to +4.0 diopters in 1.0 diopter increments. |
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P900009/S007* 8/25/99 |
Sonic Accelerated Fracture Healing System |
Paragon Biomedical, Inc. c/o Exogen, Inc. Rockville, MD 20852 |
Approval for a name change from SAFHS 2000® to Exogen 2000® . The device is indicated for the acceleration of the time to a healed fracture for fresh*, closed, posteriorly displaced distal radius (Colles') 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. *All fractures in both clinical studies were treated with SAFHS® therapy within seven days for fracture. |
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P910023/S043 8/4/99 |
Housecall™ 2.0 |
St. Jude Medical, Inc. Sunnyvale, CA 94086-6527 |
Approval for the transtelephonic follow-up system. The device, as modified, will be marketed under the trade name Housecall™ 2.0 System and is indicated for use with the Ventritex® Tiered-Therapy Defibrillators. |
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P920004/S010 8/10/99 |
VasoSeal Vascular Hemostasis Device |
Datascope Corporation Montvale, NJ 07645 |
Approval for a revision to the Instructions for Use. |
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P920014/S009* 8/10/99 |
HeartMate® IP and VE LVAS |
Thermo Cardiosystems, Inc. Woburn, MA 01888-2697 |
Approval to change the material of the retaining suture that TCI includes with each implant kit from Tevdek II 7-776 to #2 NOVAFIL™. |
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P930021/S003 8/24/99 |
EMDOGAIN® |
Biora, Inc. Chicago, IL 60610 |
Approval for packaging changes for EMDOGAIN®. The following packaging changes are now approved: 1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10mg of the product in addition to the originally approved 30mg of the product. |
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P940010/S007 8/13/99 |
OPTIGUIDE Fiber Optic (DCYL Diffuser Series) |
QLT Phototherapeutics, Inc. |
Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols. |
|
P940016/S004 8/12/99 |
Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) System |
B.Braun Medical, Inc. Bethlehem, PA 18018 |
Approval for administering the SF-36 quality of life (QOL) survey on an annual basis, instead of on a quarterly basis, of rthe patient registry/post approval study of the H.E.L.P. System. |
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P950029/S005 8/25/99 |
Brio Model Numbers 212, 220, and 222 Pacemaker Systems |
ELA Medical Plymouth, MN 55441 |
Approval for access to programmable rest-rate and non-invasive physiological stimulation (NIPS) parameters. The device is indicated for dual-chamber cardiac pacing with the ability to perform limited non-invasive electrophysiological studies. |
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P950037/S007 8/4/99 |
Actros SLR+ and Kairos SL Pulse Generators; SL 60/xx-BP VDD Single-Pass Leads; and SWM 1000 B-H01.0.U. Software Cartridge |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for a VDDR single pass lead system. |
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P950037/S008 8/24/99 |
Dromos Dr, Dromos SR, Actros+, and Kairos Pacing Systems, EPR 1000PLUS Programmer with version B-H02.0.U software |
BIOTRONIK, Inc. Lake Oswego, OR |
Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS. |
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P950043/S006 8/27/99 |
Econolith™ Lithotripter |
Medispec Ltd. Montgomery Village, MD 20886 |
Approval for the final report of the postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) modifications tothe Econolith™ Lithotripter's labeling to reflect the results of the final report. Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that the postapproval requirement is now complete. |
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P960001/S005 8/26/99 |
DePuy CMW Bone Cement |
DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988 |
Approval for a manufacturing site located at DePuy International, Blackpool, Lancashire FY4 4QQ, England. |
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P960007/S006 8/5/99 |
TransCyte |
Advanced Tissue Sciences LaJolla, CA 92037-1005 |
Approval for "A Randomized, Controlled, Within-Patient-Paired Study to Compare the Effectiveness of TransCyte and Biobrane in the Treatment of Mid-Dermal to Indeterminate Depth Burn Wounds." |
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P960030/S005 8/26/99 |
Passive Plus® DX Endocardial, Steroid Eluting, Passive Fixation Leads, Model 1336T |
St. Jude Medical Sylmar, CA 91342 |
Approval for the Model 1336T Passive Plus® DX Endocardial, Steroid Eluting, Passive Fixation pacing lead. This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator. |
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P960042/S004 8/3/99 |
Spectranetics Laser Sheath Kits, 14 French and 16 French, Models 500-012 and 500-013 |
The Spectranetics Corporation Colorado Springs, CO 80907-5186 |
Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits. |
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P960057/S004 8/11/99 |
ADCON®-L Adhesion Control in a Barrier Gel |
Gliatech, Inc. Cleveland, OH 44122 |
Approval for a patient brochure. The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis. |
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P970032/S001 8/26/99 |
SalEst™ System |
Biex, Inc. Dublin, CA 94568 |
Approval for a contract packaging site located at Biotecnica Continental SA DE CV, Libramiento Oriente 124-C, Tijuana, BC 22490, Mexico. |
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P970051/S007* 8/20/99 |
Nucleus 24 Cochlear Implant System for Adults and Children – WinDPS Service Release 3 (Software) |
Cochlear Corporation Englewood, CO 80112 |
Approval for a software modification, the WinDPS Service Release 3. |
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P980001/S002 8/3/99 |
NIR ON™ Ranger w/SOX™ and NIR ON™ Ranger™ Premounted Stent Systems |
Boston Scientific Corporation Natick, MA 01760-1537 |
Approval for the postapproval study protocol for the NIR ON™ Ranger w/SOX™ and NIR ON™ Ranger™ Premounted Stent Systems. |
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P980006/S001 8/25/99 |
PureVision™ (balafilcon A) Visibility Tinted Contact Lens |
Bausch & Lomb, Inc. Vision Care Division Rochester, NY 14603-0450 |
Approval for a manufacturing site located at Bausch & Lomb Ireland, Contact Lens Plant, Unit 424/425, Industrial Estate, Cork Road, Waterford, Ireland. |
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P980016/S007 8/12/99 |
Medtronic® Model 7271 GEM® DR Implantable Cardioverter Defibrillator |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for modifications to the high power circuitry of the Medtronic® Model 7271 GEM® DR Implantable Cardioverter Defibrillator. |
|
P980035/S002 8/9/99 |
Medtronic.Sigma™ Models SDR303, SDR203, SDR306, SD303, SD203, SVDD303, SSR303, SSR203, SSR306, SS303, SS203, SS103, SS106 and SVVI103 Pulse Generators/ Medtronic.Sigma™ Model 9963/A Software |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Sigma Family of pulse generators and software. |
| 30-DAY NOTICES | |||
|---|---|---|---|
| APPLICATION NUMBER & LTR DATE | DEVICE NAME | COMPANY NAME | COMMENTS |
|
P850048/S015** 8/3/99 |
Tandem®-MP Prostate Specific Antigen Immunoenzymetric Assay |
Beckman Coulter, Inc. San Diego, CA 92196 |
The 30-day Notice requested a change in a raw material from bovine serum to bovine serum albumin, which is used in the manufacture of a component in the Tandem®-MP PSA kit to improve the consistency between lots. In addition, a change in the microplate vendor to permit an additional source of microplates and to reduce manufacturing costs |
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P890023/S008** 8/13/99 |
BIOMEDICS® 55 (ocufilcon D) UV Blocker IMT Soft (hydrophilic) Contact Lenses for Extended Wear |
Ocular Sciences, Inc. San Francisco, CA 94080 |
The 30-Day Notice requested a UV blocker process change at Ocular Sciences’ Santa Isabel facility. |
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P900056/S028** 8/9/99 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052-3376 |
The 30-Day Notice requested the use of alternate biological indicators with a reduced incubation time. |
|
P950034/S012** 8/27/99 |
Seprafilm® Bioresorbable Membrane |
Genzyme Corporation Cambridge, MA 02139-1562 |
The 30-Day Notice requested a manufacturing process change for Seprafilm® Bioresorbable Membrane. The requested change would allow the use of LabelMax software and high speed laser printers to print the entire Seprafilm® Pouch Front Label and a new 10 Pack Box/Envelop Carton Label. |
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P970020/S018** 8/13/99 |
ACS Multi-Link Duet™ Coronary Stent Systems |
Guidant Corporation Temecula, CA 92589-9018 |
The 30-Day Notice requested the elimination of the pre-expansion step for the 3.0 mm, 3.5 mm, and 4.0 mm sizes. |
* Evaluated as a "Real-Time Review" PMA Supplement
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 27
Summary of PMA Originals Under Review
Total Under Review: 87
Total Active: 53
Total On Hold: 34
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 228
Total Active: 165
Total On Hold: 63
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals: 4
Supplements: 46
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 27
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 151
Updated 4/7/2000
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