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PMA Final Decisions Rendered for March 1998

PMA Original Approvals

PMA SUPPLEMENTAL APPROVALS
APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
N17004/S011 3/18/98	Surgical Simplex® P Radiopaque Bone Cement	Howmedica, Inc. Rutherford, NJ 07070-2584	Approval for Isotron Ireland, OTD., to be certified as an alternate supplier for ETO sterilization process.
P790002/S015 3/12/98	EBI Bi-Osteogen™/Bone Healing System® FLX®-S Coils (FLX 2-S, FLX 3-S, and FLX 4-S)	Electro-Biology, Inc. A Subsidiary of Biomet, Inc. Parsippany, NJ 07054-1079	Approval for the FLX®-S Coils (model numbers FLX 2-S, FLX 3-S, and FLX 4-S) which will be used to deliver the single repetitive pulse (SRP) signal produced by the EBI Bone Healing System® Model 1020-S control unit. The device, as modified, will be marketed under the trade name EBI FLX®-S Coils and used with the EBI Bone Healing System® Model 1020-S control unit which is indicated for the treatment of nonunions, failed fusions, and congenital pseudarthroses.
P790017/S065* 3/23/98	USCI® Apollo™ Rely® SP Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel® Coating and Miniquet Device	Bard Cardiology Billerica, MA 01821	Approval for a new PTCA catheter line. The device, as modified, will be marketed under the trade name USCI® Apollo™ Rely® SP Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel® Coating and Miniquet Device 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.
P810002/S046 3/24/98	St. Jude Medical® Mechanical Heart Valve SJM® Masters Series with Silzone™ Coating	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for the addition of silver to the sewing cuff of the St. Jude Medical Mechanical Heart Valve SJM Masters Series. The device, as modified, will be marketed under the trade name St. Jude Medical Mechanical Heart Valve SJM Masters Series with Silzone Coating and will be available in the following model numbers and sizes: AS-601 and AECS-602 (19, 21, 23, 25, 27, 29, and 31 mm), MS-601 and MECS-602 (19, 21, 23, 25, 27, 29, 31, and 33 mm), and AHPS-605, MHPS-605, AEHPS-606, and MEHPS-606 (17, 19, 21, 23, 25, and 27 mm).
P810046/S186 3/13/98	Simpson-Robert® Coronary Balloon Dilatation Catheter ACS Swap-It™ Guide Wire Exchange Device	Guidant Corporation Santa Clara, CA 95052	Approval for ACS Swap-It™ Guide Wire Exchange Device which is an accessory to Guidant ACS' RX (Rail) catheters. This device will be marketed under the trade name ACS Swap-It™ Guide Wire Exchange Device and is indicated for use within a guiding catheter to facilitate the exchange of a 0.014 inch guide wire while maintaining the position of an ACS RX® (Rail) catheter.
P840024/S074 3/6/98	Nucleus 22 Channel Cochlear Implant System for Adults and Children	Cochlear Corporation Englewood, CO 80112	Approval for changes in the package insert labeling to 1) include the indication for children age 18 months to 17 years and 2) to modify the adverse effects section.
P840064/S019 3/17/98	VISCOAT® Viscoelastic Solution	Alcon Laboratories Fort Worth, TX 76134	Approval for the incorporation of VISCOAT and PROVISC, which make up the DUOVISC product, into a single plastic tray, to be sterilized and processed at Alcon's Puerto Rico facility; and a change in the sterilization process at Alcon's Puerto Rico facility for the DUOVISC System.
P840064/S020 3/3/98	VISCOAT® Viscoelastic Solution	Alcon Laboratories Fort Worth, TX 76134	Approval for a change in method of sterilization from 12/88 EtO/Freon mixture to 100% Ethylene Oxide for a 0.75 mL fill volume of VISCOAT at Alcon's Puerto Rico manufacturing facility.
P840068/S034* 3/27/98	VIGOR Pacemakers Models 950, 1230, and 1232	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.
P860022/S050 3/31/98	BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses	Polymer Technology Rochester, NY 14692	Approval for the three additional finishing laboratories listed to become additional manufacturers and distributors of the device: Premier Contact Lens, 111 28th Avenue South, Nashville, TN 37212 and Premier Contact Lens, 3614 S.Perkins, Memphis, TN 38118.
P860022/S051 3/31/98	BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses	Polymer Technology Rochester, NY 14692	Approval for the three additional finishing laboratory listed to become an additional manufacturer and distributor of the device: Diversified Ophthalmics, 1308 West 500 North, Salt Lake City, UT 84116.
P860026/S004 3/3/98	Diaphragmatic/ Phrenic Nerve Stimulator	Avery Laboratories, Inc. Commack, NY 11725-5703	Approval for bilateral stimulus output redundancy, external breathing rate control, antenna indicators which verify stimulus output and antenna integrity, concealed factory controls, additional covering to the battery connector, and design improvements to existing architecture that don't increase stimulus parameters above what was approved on 1/5/87. The device, as modified, will be marketed under the trade name Mark IV and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (RMP) or because of control alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm functions is sufficient to accommodate electrical stimulation.
P870015/S028* 3/5/98	Medstone STS™ Lithotripter	Medstone International, Inc. Aliso Viejo, CA 92656-4114	Approval for modification of the Medstone STS™ Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-40PF).
P870015/S029* 3/27/98	Medstone STS™ Lithotripter	Medstone International, Inc. Aliso Viejo, CA 92656-4114	Approval for modification of the Medstone STS™ Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-30-ESU).
P870080/S001 3/12/98	Hulka Clip Tubal Occlusion Device and Applicator Systems	Richard Wolf Medical Instruments Corporation Vernon Hills IL 60061	Approval for the instruction manual "Hulka Clips for Hulka Clip Applicators" - E36 to be included with each box of clips sold.
P890027/S043 3/6/98	Nucleus 22 Channel Cochlear Implant System for Adults and Children	Cochlear Corporation Englewood, CO 80112	Approval for changes in the package insert labeling to 1) include the indication for children age 18 months to 17 years and 2) to modify the adverse effects section.
P890047/S011 3/17/98	PROVISC® Viscoelastic Material as DUOVISC® Viscoelastic System	Alcon Laboratories Fort Worth, TX 76134	Approval for the incorporation of VISCOAT and PROVISC, which make up the DUOVISC product, into a single plastic tray, to be sterilized and processed at Alcon's Puerto Rico; and a change in the sterilization process at Alcon's Puerto Rico facility for the DUOVISC System.
P890055/S004 3/17/98	Arrow Model 3000-16 Constant Flow Implantable Pump with Bolus Safety Valve	Arrow International Walpole, MA 02081	Approval for the Arrow Model 3000-16 Constant Flow Implantable Pump with Bolus Safety Valve for adult use for the following indications: 1)the intraspinal delivery of preservative free morphine for patients with intractable chronic pain, 2) the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.
P900023/S025 3/13/98	BVS 5000 Bi-Ventricular Support System	ABIOMED, Inc. Danvers, MA 01923	Approval for four new 32 French atrial cannulae which are 90 Bend with Lighthouse Tip, Straight with Lighthouse Tip, 90 Bend with Beveled Tip, and Straight with Beveled Tip.
P920034/S002 3/5/98	Tripter-X1 Series Shockwave Lithotripters	Medirex, Inc. Wellesley Hills, MA 02181	Approval for non-electrocardiographic (ECG) gating in patients with renal and upper tract calculi.
P930016/S006* 3/20/98	VISX STAR S2 Excimer Laser System (formerly Model "C")	VISX, Inc. Santa Clara, CA 95051-0703	Approval for 1) laser removal of the epithelium; 2) visibility upgrade; 3) swivel mounted vacuum nozzle; 4) integrated hardware module with all unapproved indications "locked out"; 5) variable Hertz rate from 1.5 to 10 Hertz; 6) smoothing; 7) installation of software Version 2.2 with all unapproved indications "locked out"; and, 8) revised Operator's Manual. The device as modified will be marketed under the trade name VISX START S2 Excimer Laser System and is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0mm major axis. The PRK procedure is intended for use: 1) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patient 18-20 years of age in PRK treatment for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0D spherical equivalent at the corneal plane with less than or equal to -1.0D of astigmatism; or 3) in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0D spherical myopia at the spectacle plane and up to -4.0D of astigmatism.
P930034/S009 3/11/98	SVS Apex Plus Excimer Laser Workstation and emphasis® disc for myopic astigmatic photorefractive keratectomy (Toric PRK)	Summit Technology, Inc. Waltham, MA 02154	Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis® disc. These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a stable manifest refraction(1D) over the past year; and, 3) in patients who are 21 years of age or older.
P940008/S009 3/17/98	Res-Q™ Micron ICD Models 101-10 and 101-10A Res-Q™ Micron ICD Models 101-05, 101-09	Sulzer Intermedics, Inc. Angleton, TX 77515-2523	Approval for new Models of Res-Q™ Micron ICD (Models 101-10 and 101-10A) and modifications to the existing Res-Q™ Micron ICD Models 101-05, and 101-09.
P940022/S004 3/17/98	CLARION® Mult-Strategy Cochlear Implant (for adults)	Advanced Bionics™ Corporation Sylmar, CA 91342	Approval of a modified ICS lead electrode, i.e., the Flex Lead Electrode.
P940031/S012* 3/27/98	VIGOR Pacemakers Models 950, 1230, and 1232	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.
P950014/S011 3/13/98	Prostatron™ Praktis	EDAP Technomed, Inc. Burlington, MA 01803	Approval for a new hardware and software configuration of the Prostatron™. The device, as modified, will be marketed under the trade name Prostatron™ Praktis and is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH). It is intended that the Prostatron™ Praktis deliver a complete thermal therapy treatment during a single treatment session. The Prostatron™ Praktis is available with two treatment protocols, each requiring a unique treatment catheter. Protocol 2.0, which uses the standard Prostaprobe (Black) treatment catheter, is indicated for patients with prostatic lengths of 35 to 50 mm. The higher energy Protocol 2.5, which uses the Prostaprobe (Blue) treatment catheter, is indicated for patients with prostatic lengths of 25 to 50 mm in whom the benefits of obstructive improvement outweigh the attendant risks.
P950014/S013* 3/10/98	Prostatron™	EDAP Technomed, Inc. Burlington, MA 01803	Approval for 1) the addition of a barcode identification label to the Prostaprobe, and 2) modifications to the Prostatron™ Maxis and dual module configurations to require entry of the Prostaprobe barcode information prior to treatment.
P950035/S001* 3/20/98	NeuroControl Freehand System	NeuroControl Corporation Cleveland, OH 44106-4720	Approval for a change in the supplier of the Platinum-Iridium (Pt-Ir) electrode discs used in the manufacture of the Freehand Epimysial Electrodes and a change in the Model Numbering for the Freehand System.
P950037/S001 3/13/98	Actros DR, D, SR, and S Pulse Generators; PMS 1000 and PMS 1000 C Programmers; and SWM 1000, Version F01.B00.U Software Module	Biotronik, Inc. Lake Oswego, OR 97035-5369	Approval for a capacitive sensor, integrated circuit change and its supporting circuitry, hybrid circuit modification, battery change, pacemaker housing change, modified header, PMS 1000 C programmer, and the SWM 1000 F01.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 F01.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 increase 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 conudction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P960009/S001 3/27/98	Medtronic Activa Tremor Control System	Medtronic Neurological Minneapolis, MN 55440-9087	Approval for three of the four conditions of approval, i.e., studies to further characterize long term safety and effectiveness, obtain follow-up mortality and autopsy information, and evaluate patients following implantation of multiple leads and implantation of replacement leads.
P960013/S001 3/19/98	Tendril DX Model 1388T, 1388K, and 1388T/C Steroid Eluting, Screw-In Pacing Leads	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Approval for the use of Thermedics Tecothane T11075D-M for molded polyurethane components as a replacement for Pellethane 2363-75D. FDA also acknowledges your marketing of the Tenril DX Model 1388T/C lead, which is identical to the approved Model 1388t lead, except that it is packaged only with the clip-on tool accessory.
P960040/S003 3/13/98	VENTAK® AV™ II DR AICD™ System	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	Approval for the VENTAK® AV™ II DR pulse generator Models 1821 and 1826, Model 2843 Application Software, Version 1.3 and revisions to the Physician's Manual, Package Labeling and Patient's Manual.
P960058/S003 3/17/98	CLARION® Multi-Strategy Cochlear Implant (for children)	Advanced Bionics™ Corporation Sylmar, CA 91342	Approval of a modified ICS electrode, i.e., the Flex Lead Electrode.
P970021/S001 3/6/98	ThermaChoice Uterine Balloon Therapy System	Gynecare, Inc. Menlo Park, CA 94025	Approval for a new manufacturing site located at SeaMed Corporation, 21621 30th Ave., NE, Bothell, WA 98021.

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

30-DAY NOTICES
APPLICATION NUMBER & LTR DATE	DEVICE NAME	COMPANY NAME	COMMENTS
P970002/S001** 3/23/98	Monostrut Cardiac Prosthesis	Alliance Medical Technologies Irvine, CA 92614	The 30-day Notice requested that FDA review a change in a manufacturing process which involves eliminating the cytotoxicity testing that was a required lot release parameter for the Monostrut heart valves.
P970003/S008** 3/13/98	NeuroCybernetic Prosthesis System Model 100 Pulse Generator	Cyberonics, Inc. Houston, TX 77058	The 30-day Notice requested that FDA review a change in a manufacturing process. A laser marking process which is equivalent ot the process already performed by a subcontractor for Cyberonics is being brought in-house to simplify the manufacturing process.
P970003/S009** 3/13/98	NeuroCybernetic Prosthesis System	Cyberonics, Inc. Houston, TX 77058	The 30-day Notice requested that FDA review a change in the header pouring process on the pulse generator can. This change would improve the efficiency of the process and the cosmetic appearance of the finished product.

**A 135 Day Supplement Was Not Required

SUMMARY STATISTICS FOR PMA ORIGINALS & SUPPLEMENTS

Summary of PMA Originals & Supplements Approved

Originals: 3
Supplements: 34

Summary of PMA Originals Under Review

Total Under Review: 73
Total Active: 31
Total On Hold: 42
Number Under Review and Greater Than 180 Days: 4

Summary of PMA Supplements Under Review

Total Under Review: 219
Total Active: 134
Total On Hold: 83
Number Under Review and Greater Than 180 Days: 5

Summary of All PMA Submissions Received

Originals: 5
Supplements: 43

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 34
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 206.4
Number Under Review and Greater Than 180 Days: 9

Updated May 26, 1998

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