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PMA Final Decisions Rendered for May 1998 |
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 |
---|---|---|---|
P950032
5/22/98 |
Apligraf | Organogenesis, Inc.
Canton, MA 02021 |
This device is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. |
P960057
5/27/98 |
ADCON®-L Adhesion Control in a Barrier Gel | Gliatech, Inc.
Cleveland, OH 44122 |
This device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis. |
P970026
5/29/98 |
SoundScan 2000 and SoundScan Compact | Myriad Ultrasound Inc.
Englewood, NJ 07631 |
The intended use of the device is to Perform quantitative ultrasound measurement of tibia (shin bone), the results of which can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. The device measures the velocity of ultrasound (speed of sound, SOS, in m/sec) along the tibia, exclusively within bone, unaffected by overlying soft tissue. SOS along the tibia provides an index of bone strength, with stronger bone having higher velocities. The device provides a measure of skeletal fragility. The device reports SOS along with both T- and Z-scores. |
P970044
5/29/98 |
Urowave® Microwave Thermotherapy System | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
This device is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with prostatic lengths between 30 mm and 55 mm. |
PMA SUPPLEMENTAL APPROVALS | |||
---|---|---|---|
APPLICATION NUMBER/ DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION/ INDICATIONS |
P780012/S008
5/12/98 |
Abbott Imx® HAVAB® | Abbott Laboratories
Abbott Park, IL 60064-3500 |
This device is indicated for the qualitative determination of total antibody to hepatitis A antigen in human serum or plasma. |
P790005/S040*
5/1/98 |
OsteoGen Bone Growth Stimulator | Electro-Biology, Inc.
Parsippany, NJ 07054-1079 |
Approval for the addition of a 8-cm mesh cathode to be used with the EBI OsteoGen Bone Growth Stimulator. |
P790017/S066*
5/18/98 |
USCI® Apollo Rely® Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel® Coating and Miniquet Device | Bard Cardiology
Billerica, MA 01821 |
Approval for the addition of three balloon sizes to the device. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
P810037/S010
5/22/98 |
Kontron Kolormon Plus BloodGas Module 7267-505 | Cardiopulmonary Corp.
Milford, CT 06460 |
Approval for conversion of the stand-alone MicroGas 7640 P02/PC02 Monitor to a plug-in module for the Kolormon Plus host. The device is indicated for cutaneous measurement of blood gas tensions (P02 or PC02) |
P810046/S183
5/14/98 |
ACS RX Rocket and ACS Avenger Coronary Dilatation Catheters | Guidant Corporation
Santa Clara, CA 95052-8167 |
Approval for design modifications and additional balloon sizes for the ACS RX Rocket Coronary Dilatation Catheter. |
P810046/S189
5/27/98 |
ACS RX ESPRIT PTCA Catheters | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for an alternate E-beam sterilization facility located at Titan Scan Systems, 9020 Activity Rd., Suite D, San Diego, CA 92126. |
P830026/S071
5/21/98 |
Edgeband Pacer | Sulzer Intermedics, Inc.
Angleton, TX 77515 |
Approval for the following pacemakers which incorporate the Edgeband Design: Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and the Quantum III Model 254-27E. Approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the following additional models: the Side-Lock implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators. |
P830055/S056*
5/14/98 |
New jersey LCS® Total Knee System | Depuy, Inc.
Warsaw, Inc. 46581-0988 |
Approval for a trade name change from the New Jersey LCS® Total Knee System to the LCS® Total Knee System. |
P830055/S057*
5/1/98 |
LCS Total Knee System | DePuy, Inc.
Warsaw, IN 46581-0988 |
Approval for the addition of posterior stabilized femoral and tibial bearing components and rotating platform (RP II) tibial trays and bearing components to the LCS® Total Knee System. |
P830055/S059*
5/14/98 |
LCS® Total Knee System | DePuy, Inc.
Warsaw, IN 46581-0988 |
Approval for the use of multilingual package labeling and a multilingual package insert for the components of the LCS® Total Knee System. |
P840002/S008
5/7/98 |
STAT-Pace II Esophageal Pacing System | Seecor, Inc.
Mesquite, TX 75149 |
Approval for relocation of Seecor's manufacturing facility to Seecor, 844 Dalworth Drive, Suit #6, Mesquite, TX 75149. |
P840008/S062
5/14/98 |
Dornier Lithotripter and Dornier Compact S Lithotripter | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
Approval for hardware and software modifications to the Dornier Lithotripter and Dornier Compact S Lithotripter, including modifications to the shock wave therapy source of each system. |
P840068/S035*
5/28/98 |
DELTA Pacemaker System: VIGOR DDD Model 950 | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software. |
P850007/S021
5/14/98 |
Spinal-Stim® Lite Spinal Fusion System, Model 212LE | Orthofix, Inc.
Richardson, TX 75081 |
Approval for the Spinal-Stim® Lite Spinal Fusion System, Model 212LE. The device will be marketed under the trade name Spinal-Stim® and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery. |
P850035/S023*
5/1/98 |
SpF Implantable Spinal Fusion Stimulator | Electro-Biology, Inc.
Parsippany, NJ 07054-1079 |
Approval for the addition of a 4cm mesh cathode to be used with the SpF-2T stimulator and a 8cm mesh cathode to be used with the SpF-XL IIb stimulator. The device, as modified, will be marketed under the trade names SpF-2T/CM and SpF-XL IIb 2/DM and is indicated for the same used as the SpF-2T and SpF-XL IIb. |
P860004/S039
5/21/98 |
Medtronic® SynchroMed Infusion System | Medtronic Neurological
Minneapolis, MN 55440-9087 |
Approval for implementation of the Medtronic® InDura® 1P One Piece Intrathecal Catheter Model 8709 with your SynchroMed Infusion System. |
P860019/S142*
5/13/98 |
SCIMED® 9 mm NC Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval to extend the product line of the SCIMED® NC Ranger PTCA Catheter to include a 9 mm length balloon with diameters ranging from 2.5 mm to 4.0 mm in 0.25 mm increments. The device, as modified, will be marketed under the trade name SCIMED® 9 mm NC Ranger PTCA Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
P870072/S005
5/21/98 |
Thoratec® Ventricular Assist Device (VAD) System | Thoratec Laboratories Corporation
Pleasanton, CA 94588 |
The device is indicated for post-cardiotomy patients who are unable to be weaned from cardiopulmonary bypass. |
P880006/S026
5/7/98 |
Regency SC+/SC/SCX Single Chamber Pulse Generators | St. Jude Medical
Sylmar, CA 91342 |
Approval for the Regency SC+, Regency SC, and Regency SCX Pulse Generators which are programmed by the APS II Programmer with Model 3204a Function Pack. |
P890003/S056*
5/21/98 |
Model 9790C Programmer with Model 9891 PE Software | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for a hardware upgrade to the Model 9790C Programmer (from a Intel 80486 to an Intel Pentium MMX 166 MHz) and the Model 9891 PE Software. |
P900023/S027*
5/28/98 |
ABIOMED® BVS 5000 Bi-Ventricular Support System | ABIOMED, Inc.
Danvers, MA 01923 |
Approval for a change in the manufacturing process to allow the outflow connector to be annealed prior to assembly of the blood pump. |
P910020/S021
5/21/98 |
Edgeband Pacer | Sulzer Intermedics, Inc.
Angleton, TX 77515 |
Approval for the following pacemakers which incorporate the Edgeband Design: Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and the Quantum III Model 254-27E. Supplement is approved for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the folowing additional models: the Side-Lock implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators. |
P910030/S008 5/5/98 |
Gianturco-Roubin Flex-Stent Coronary Stent
GR II Coronary Stent |
Cook, Inc.
Bloomington, IN 47402 |
Approval for a labeling change in the Instructions for Use ("Technical Information and Suggested Instructions for Placement") of the GR II Coronary Stent. |
P910031/S015
5/1/98 |
Oracle MegaSonics Five-64 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Endosonics Corporation
Rancho Cordova, CA 95670 |
Approval for Oracle MegaSonics Five-64 PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five- 64 PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image. |
P930027/S003
5/8/98 |
Immulite PSA | Diagnostic Products Corporation
Los Angeles, CA 90045 |
Approval for adding information on the percentage for each PSA range for healthy male subjects as one group in the expected value section. |
P940022/S005
5/28/98 |
CLARION® Multi-Strategy Cochlear Implant | Advanced Bionics Corporation
Sylmar, CA 91342 |
Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the CIM 3. |
P940031/S013*
5/28/98 |
VIGOR DR Pacemaker System | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software. |
P940034/S004
5/15/98 |
Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test (MTD) | Gen-Probe, Inc.
San Diego, Ca 92121-4362 |
Approval for:1)reagent manufacturing modifications that include reformulation of the specimen dilution buffer and enzyme dilution buffer reagents; packaging of the amplification reagent in one vial, a modified lyophilization cycle for the hybridization reagent, and an increased volume of reconstituion buffer provided; 2) kit configuration changes that include deletion of the termination reagent and hybridization controls; and 3)assay protocol changes that include use of increased sample size, decreased volume of specimen dilution buffer, reduced amplification time, increased selection time, and elimination of the termination step. |
P950002/S006
5/12/98 |
BAK Interbody Fusion System | Spine-Tech, Inc.
Minneapolis, MN 55439-2029 |
Approval for a new manufacturing site for the BAK and BAK/Proximity implants, Riteway Precision Machine, Inc. |
P950005/S001
5/7/98 |
Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter | Cordis Webster, Inc.
Baldwin Park, CA 91706 |
Approval for the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters - Thermistor and Non-Temperature Sensing Model and Interface Cables used with the EP Technologies 1000 RF Generator. |
P950009/S002
5/5/98 |
AutoPap® Primary Screening System | NEOPATH, Inc.
Redmond, WA 98052 |
The device is an automated cervical cytology screening device to be used in the initial screening of Papanicolaou smear slides. It identifies up to 25% of successfully processed slides as requiring no further review. The device also identifies at least 15% of all successfully processed slides for a second manual review. The device is to be used only on conventionally prepared Pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the lab as "high risk". Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director. |
P950043/S002
5/5/98 |
ECONOLITH LITHOTRIPTER | MEDISPEC LTD
Gaithersburg, MD 20879 |
Approval for non-synchronized ESWL, addition of a ECG simulator/adapter, and appropriate labeling revisions. |
P950043/S004*
5/21/98 |
ECONOLITH Model 2000 Lithotripter System | MEDISPEC LTD
Montgomery Village, MD 20886 |
Approval for minor labeling and hardware changes. |
P960007/S002*
5/29/98 |
Dermagraft-TC | Advanced Tissue Sciences
La Jolla, CA 92037-1005 |
Approval for a post approval study assessing the incidence of burn wound infection in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require such a covering prior to autograft placement. |
P960007/S004*
5/12/98 |
Dermagraft-TC | Advanced Tissue Sciences
La Jolla, CA 92037-1005 |
Approval for the new product label and directions for use for the new indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. |
P960007/S007*
5/29/98 |
Dermagraft-TC | Advanced Tissue Sciences
La Jolla, CA 92037-1005 |
Approval for a post approval study assessing the incidence of burn wound infection in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patinets who require such a covering prior to autograft placement. |
P960010/S001
5/21/98 |
Medtronic Model 6322 Wiktor® Rival Coronary Stent System | Medtronic Interventional Vascular
San Diego, CA 92121-2256 |
Approval for the Medtronic Model 6322 Wiktor® Rival Coronary Stent System. This device is indicated for the treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary arteries and bypass grafts vessels with reference diameters in the range of 3.0 to 4.5mm. |
P960019/S002*
5/5/98 |
MobilExcimer® for Phototherapeutic Keratectomy (PTK) and Photorefractive Keratectomy (PRK) Treatment for the Correction of Myopia 0 to -12.00 Diopters(D) with and without Astigmatism up to -4.00 D | LaserVision Centers, Inc.
St. Louis, MO 63141 |
Approval for two additional indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name MobilExcimer® for PTK and PRK. The MobilExcimer® for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S1) and the new indications contained in this supplement. |
P960058/S004
5/28/98 |
CLARION® Multi-Strategy Cochlear Implant (for Children) | Advanced Bionics Corporation
Sylmar, CA 91342 |
Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the CIM 3. |
P970012/S001*
5/21/98 |
Kappa 400 Pacemaker System with Model 9952A Software | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for an update to the Medtronic.Vision Software Model 9952 - Series 2.0. The update will add the ability to program the Medtronic.Kappa 400 Models KDR 401/403, KSR 401/403, the Medtronic DX2 Models 7970/7972, and will add Electrophysiological Studies (EPS) capability to the Kappa 400 pacemakers. The update also incorporates performance enhancements which shorten boot and application load times, provide quicker screen transitions, and reporting and usability enhancements. |
P970052/S002
5/19/98 |
Guardian Balloon Coronary Dilatation Catheter | CardioVascular Dynamics, Inc.
Irvine, CA 92616 |
Approval for modifications to the Guardian Balloon Coronary Dilatation Catheter. |
*Evaluated as a "Real-Time Review" PMA Supplement.
30-DAY NOTICES | |||
---|---|---|---|
APPLICATION NUMBER& LTR DATE | DEVICE NAME | COMPANY NAME | COMMENTS |
P890049/S004
5/29/98 |
LL-55,
Methafilcon A Soft (hydrophilic) contact lens for extended wear |
Biocompatibles Eyecare, Inc.
Norfolk, VA 23507 |
The requested change will allow release of finished product terminally sterilized by steam sterilization using parametric criteria rather than the existing Biological indicators. |
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 40
Summary of PMA Originals Under Review
Total Under Review: 76
Total Active: 42
Total On Hold: 34
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 224
Total Active: 141
Total On Hold: 83
Number Greater Than 180 Days: 9
Summary of All PMA Submissions Received
Originals: 7
Supplements: 34
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 40
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 155
Number Greater Than 180 Days: 6
Updated 6/8/1999
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