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PMA Final Decisions Rendered for August 1998

PMA Original Approvals

PMA SUPPLEMENTAL APPROVALS
APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
N50510/S081 8/14/98	Vitek Systems "General Susceptibility Card"	bioMerieux Vitek, Inc.	Approval for the testing of Escherichia coli, Klebsiella pneumoniae, and K. oxytoca for the presence of extended-spectrum beta lactamases (ESBL).
P790007/S014 8/20/98	Medtronic FREESTYLE® Aortic Root Bioprosthesis, Hancock® Porcine Bioprosthesis, and Hancock® Modified Orifice Porcine Bioprosthesis	Medtronic Cardiac Surgery Minneapolis, MN 55440	Approval for an alternate polyester for use in the sewing ring of the three heart valves.
P790018/S033 8/6/98	Medtronic Hall Mechanical Heart Valve	Medtronic, Inc. Minneapolis, MN 55440	Approval for relocation of manufacturing facility from Medtronic, Inc., Cardiovascular Business Center, Minneapolis, MN, to Medtronic, Inc., 8299 Central Ave., NE, Spring Lake Park, MN.
P820083/S025* 8/27/98	Gore-Tex	W.L. Gore & Assoc., Inc. Flagstaff, AZ 86033-2300	Approval for 1) a change in suture needle material, 2) a change in suture needle geometry, and 3) addition of a silicone coating to the suture needle.
P830026/S073* 8/6/98	Cosmos II 284-05, Cosmos III 284-09, Relay 294-03, -03E, Stride 294-05, Marathon DR 294-09, -09Z, 10, Unity 292-07, and Momentum 294-23, -23Z, -23E	Sulzer Intermedics, Inc. Angleton, TX 77515	Approval for modifications of the SideLock subsystem.
P830061/S027 8/27/98	CapSure® SP Novus Steroid Eluting, Tined, Transvenous Pacing Leads Models 4092 and 4592 Vitatron Excellence PS+ Steroid Eluting, Tined, Transvenous Pacing Leads Models IMK49B and IMK49JB	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for new pacing leads models. The devices, as modified, will be marketed under the trade names CapSure® SP Novus Models 4092 and 4592 and Vitatron Excellence PS+ Models IMK49B and IMK49JB and are indicated for permanent pacing and sensing of the atrium or ventricle.
P830061/S028 8/12/98	Cardioventus Defibrillators and Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P840008/S066* 8/21/98	Dornier Compact Delta Lithotripter- Stationary, Mobile, and Transportable (FS2000 X-ray Module)	Dornier Medical Systems, Inc. Kennesaw, GA 30144	Approval for modifications to the X-ray modules, changes to the device labeling, and approval of the mobile and transportable versions of the Compact Delta.
P840068/S037* 8/26/98	Vigor SSI Model 460 and Vigor SR Model 1130	Guidant Corporation St. Paul, MN 55112-5798	Approval for minor changes to the pacemaker top (header) and minor labeling changes for the Vigor SSI, Model 460 and Vigor SR, Model 1130.
P850007/S022 8/13/98	Physio-Stim® Lite Bone Growth Stimulator	Orthofix, Inc. Richardson, TX 75081	Approval for a modification to the definition of non-union in the labeling (i.e., a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).
P850007/S023* 8/14/98	Physio-Stim® Lite Bone Growth Stimulator	Orthofix, Inc. Richardson, TX 75081	Approval for the elimination of daily shut down after three hours of use and a change in the overall device lock-up time from 270 days to 365 days.
P850089/S039 8/12/98	Cardioventus Defibrillators and Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P860019/S129 8/20/98	SCIMED® NC Ranger and NC Rebel Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for a new indication for the SCIMED® NC Ranger and NC Rebel PTCA Catheters. The new indication is post-delivery expansion of balloon expandable stents.
P860019/S140 8/24/98	SCIMED® NC Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for a modified WRAP-ITTM Accessory Tool for use with the SCIMED® NC PTCA Catheters.
P860019/S146* 8/10/98	SCIMED® COYOTETM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for the following additional models of the COYOTETM PTCA Catheter: a) the addition of ¼ mm balloon diameter sizes from 2.25mm to 3.75mm for the 20mm balloon length; b) balloon lengths of 9mm, 15mm, and 25mm in balloon diameters of 2.5mm to 4.0mm in ¼mm increments; and c) balloon lengths of 30mm and 40mm in balloon diameters of 2.0mm to 4.0 mm in ¼ mm increments. These PTCA catheter models are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The 2.5mm - 4.0mm balloon models are also indicated for the post-delivery expansion of balloon expandable stents.
P860019/S147 8/6/98	SCIMED® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for changes to the instructions for use regarding the proper removal of the catheter from the packaging.
P860057/S006 8/26/98	Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis	Baxter Healthcare Corporation Santa Ana, CA 92711-1150	Approval for closure of the PMA post-approval study for the Model 2700.
P870018/S017 8/26/98	Lithostar® Multiline	Siemens Medical Systems Iselin, NJ 08830	Approval for a new configuration of the Lithostar®. The device, as modified, will be marketed under the trade name Lithostar® Multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm.
P870056/S006 8/7/98	Carpentier-Edwards® Bioprostheses Models 2625 (aortic) and 6625 (mitral)	Baxter Healthcare Corporation Santa Ana, CA 92711-1150	Approval for adding the Model 4300 valved conduit, and is indicated for correction of pulmonary stenosis or atresia and complex congenital malformations requiring Rastelli-type operations, and for correction of tricuspid atresia.
P870078/S004 8/20/98	Medtronic FREESTYLE® Aortic Root Bioprosthesis, Hancock® Porcine Bioprosthesis, and Hancock® Modified Orifice Porcine Bioprosthesis	Medtronic Cardiac Surgery Minneapolis, MN 55440	Approval for an alternate polyester for use in the sewing ring of the three heart valves.
P880003/S071 8/4/98	Cordis PTCA Dilatation catheters TitanTM and TitanTM XL PTCA Dilatation Catheters	Cordis Corporation Miami Lakes, FL 33014	Approval for a new indication for use: the post-delivery expansion of the Palmaz-SchatzTM Coronary Stent, with the TitanTM and TitanTM XL PTCA Dilatation Catheters (3.0mm, 3.25mm, 3.5mm, 3.75mm balloon diameters with 9mm and 18mm balloon lengths, and a 4.0mm balloon diameter with 9mm balloon length.)
P880003/S074* 8/10/98	Cordis ChargerTM PTCA Dilatation Catheters	Cordis Corporation Miami Lakes, FL 33014	Approval for addition of 1.5mm and 2.0mm balloon diameters with 20, 30 and 40mm balloon lengths, and 4.5mm and 5.0mm balloon diameters with 20mm balloon length to the ChargerTM PTCA Dilatation Catheter line.
P880027/S052 8/27/98	Bypass SpeedyTM Monorail® PTCA Dilatation Catheters	Schneider (USA), Inc. Minneapolis, MN 55442	Approval for a new PTCA catheter. The device, as modified, will be marketed under the trade name Bypass SpeedyTM Monorail® PTCA Dilatation 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.
P890003/S055 8/12/98	Cardioventus Defibrillators and Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P900043/S010 8/20/98	PALMAZ-SCHATZTM Balloon-Expandable Stent with Power-GripTM Over-the-Wire Delivery System	Cordis Corporation Warren, NJ 07059	Approval for a decrease in the distal balloon leg length of the PowerGripTM delivery catheter from 3mm to 1mm.
P900043/S012 8/4/98	PALMAZ-SCHATZTM Crown Balloon Expandable Stent with Power GripTM Over-the-Wire Delivery System	Cordis Corporation Warren, NJ 07059	Approval for the indication of treatment of restenotic native coronary artery lesions with a reference diameter in the range of 3-4 mm, and modifications to the current label that includes addition of the Stars Trial results to the clinical summary section.
P900056/S022 8/6/98	RotaWireTM Floppy Gold Guide Wire	Boston Scientific Corporation Redmond, WA 98052-3376	Approval for the RotaWireTM Floppy Gold Guide Wire for use with the Rotablator® Rotational Angioplasty System.
P910020/S023* 8/6/98	Cosmos II 284-05, Cosmos III 284-09, Relay 294-03, -03E, Stride 294-05, Marathon DR 294-09, -09Z, 10, Unity 292-07, and Momentum 294-23, -23Z, -23E	Sulzer Intermedics, Inc. Angleton, TX 77515	Approval for modifications of the SideLock subsystem.
P910073/S024 8/13/98	ENDOTAK® ENDURANCETM Endocardial Defibrillation Lead Models 0134, 0135, 0136 and Accessory Stylet Models 6971, 6972	Guidant Corporation St. Paul, MN 55112-5798	Approval for a design change to provide higher pacing impedance. The device, as modified, will be marketed under the trade name ENDOTAK® EnduranceTM Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and delivery cardioversion and defibrillation shocks for AICD automatic implantable cardioverter defibrillator systems.
P920015/S014 8/12/98	Cardioventus Defibrillators and Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P920048/S002 8/14/98	Fetal Fibronectin Point of Care Testing System	Adeza Biomedical Corporation Sunnyvale, CA 94089	Approval for a rapid, qualitative test for detecting the presence of fetal fibronective (fFN) in cerviocovaginal secretions. The device, as modified, will be marketed under the trade name Fetal Fibronectin Rapid System and is indicated as an aid to rapidly assess the risk of preterm delivery in £ 7 or £ 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (<3 cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The device is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in £ 34 weeks, 6 days when a cerviocovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.
P930012/S012 8/25/98	LaCrosseTM PTCA and ChampionTM PTCA Catheter Product Lines	United States Surgical Corporation Norwalk, CT 06856	Approval for a change in labeling for the LaCrosseTM PTCA and ChampionTM PTCA Catheter Product Lines. Specifically, the change included a reduction in the labeled rated burst pressures fro the 2.5mmx20mm, 3.0mmx30mm, and 3.5mmx30mm LaCrosseTM PTCA Catheters and the 2.0mmx20mm ChampionTM PTCA Catheter.
P930029/S012 8/14/98	Atakr Radiofrequency Catheter Ablation System	Medtronic Cardio Rhythm Shoreview, MN 55126-2978	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc., Road 149, Km. 56.3, Villalba, Puerto Rico 00755.
P930039/S006 8/12/98	Cardioventus Defibrillators and Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P940031/S014* 8/26/98	Vigor SSI Model 460 and Vigor SR Model 1130	Guidant Corporation St. Paul, MN 55112-5798	Approval for minor changes to the pacemaker top (header) and minor labeling changes for the Vigor SSI, Model 460 and Vigor SR, Model 1130.
P940031/S017* 8/21/98	MERIDIAN and DISCOVERY Pacemaker Systems	Guidant Corporation St. Paul, MN 55112-5798	Approval for modifications to the DISCOVERY and MERIDIAN pacemakers consisting of changes to the firmware to enhance the performance of existing diagnostic features, and a hardware change to the mixed mode integrated curcuit chip to increase the maximum selectable pacing amplitude.
P950014/S015 8/19/98	Prostatron Praktis	EDAP Technomed, Inc. Burlington, MA 01803	Approval for: 1) the use of an alternate thermometry system (Luxtron Model 3204), with related changes to the Prostaprobe and software; 2) the use of an upgraded microprocessor in the main computer; 3) a change of the material of several cabinet panels from metal to plastic; and 4) the addition of electromagnetic shielding to the cooling system regulation board.
P950019/S004* 8/27/98	Ray Threaded Fusion Cage (TFC)TM with instrumentation	United States Surgical Corporation Norwalk, CT 06856	Approval for modified labeling and labeling procedures for the instruments.
P950024/S001	Cardioventus Defibrillators and Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P950034/S008 8/18/98	SeprafilmTM Bioresorbable Membrane	Genzyme Corporation Cambridge, MA 02139-1562	Approval for the extension of the expiration dating period for Seprafilm® Bioresorbable Membrane from 24 months to 30 months.
P950037/S002 8/13/98	Actros DR, D, SR, and S Pulse Generators; PMS 1000 and PMS 1000 C Programmers; and SWM 1000, Version F03.B00.U Software Module	Biotronik, Inc. Lake Oswego, OR 97035-5369	Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C Programmer, and the SWM 1000 F03.B00.U Software. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U). Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to: sick sinus syndrome (i.e., bradycardiatach-cardia syndrome, sinus arrest, sinus bradycardia), sino- atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P950037/S003 8/13/98	Actros DR, D, SR, and S Pulse Generators; PMS 1000 and PMS 1000 C Programmers; and SWM 1000, Version F03.B00.U Software Module	Biotronik, Inc. Lake Oswego, OR 97035-5369	Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C Programmer, and the SWM 1000 F03.B00.U Software. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U). Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrome (i.e., bradycardiatach-cardia syndrome, sinus arrest, sinus bradycardia), sino- atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P960001/S007* 8/27/98	Endurance Bone Cement	DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988	Approval for the inclusion of Endurance Bone Cement within a pre-packaged "kit" for cemented hip or knee replacement procedures.
P960007/S008 8/14/98	TransCyteTM	Advanced Tissue Sciences La Jolla, CA 92037-1005	Approval for changing the name of the product from Dermagraft-TC to TransCyteTM and for minor editorial changes to the Directions for Use and product label. The device, as modified, will be marketed under the trade name TransCyteTM and is indicated for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
P960040/S006 8/31/98	VENTAK® AV III DR AICDTM System	Guidant Corporation St. Paul, MN 55112-5798	Approval for the VENTAK® AV III DR AICDTM System with Model 2843 Software, Version 2.6, the use of Version 2.6 with the VENTAK® AV II DR System and modifications to the Physician's Manual and the Patient's Manual.
P970020/S001 8/4/98	ACS Multi-LinkTM Coronary Stent System	Guidant Corporation Santa Clara, CA 95052	Approval for ACS RX Multi-Link HPTM Coronary Stent System with the 25mm stent length.
P970031/S006 8/20/98	Medtronic FREESTYLE® Aortic Root Bioprosthesis, Hancock® Porcine Bioprosthesis, and Hancock® Modified Orifice Porcine Bioprosthesis	Medtronic Cardiac Surgery Minneapolis, MN 55440	Approval for an alternate polyester for use in the sewing ring of the three heart valves.

*Evaluated as a "Real-Time Review" PMA Supplement.

Originals: 6
Supplements: 48

Total Under Review: 72
Total Active: 35
Total On Hold: 37
Number Greater Than 180 Days: 2

Total Under Review: 227
Total Active: 154
Total On Hold: 73
Number Greater Than 180 Days: 7

Summary of All PMA Submissions Received
Originals: 4
Supplements: 68

Summary of PMA Supplement PMA Approval/Denial Decision Times

Updated 8/12/1999

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