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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.

PMA Original Approvals

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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