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PMA Final Decisions Rendered for November 1998 |
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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.
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| D970012
11/2/98 |
AMS 700 Series Inflatable Penile Prosthesis Product Line: AMS 700CX, AMS 700CXM, AMS 700CX Preconnect, AMS 700 Ultrex, and AMS 700 Ultrex Plus | American Medical Systems, Inc. Minnetonka, MN 55343 | The FDA has completed its review of the notice of completion (NOC) for the AMS 700 Series Inflatable Penile Prosthesis Product Line. This device is indicated for use in the treatment of chronic, organic, male erectile dysfunction (impotence). This PDP is declared completed. |
| P970043
11/2/98 |
LADARVision® Excimer Laser System | Autonomous Technologies Corporation
Orlando, FL 32826 |
Indicated for use in photorefractive keratectomy (PRK) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1.00D to -10.00D of sphere and less than or equal to -4.00D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50D and -10.00D spherical equivalent (SE) at the spectacle plane where sphere or cylinder is at least 1.00D; 2) who are 21 years of age or older; and 3) with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.50D for corrections up to -7.00D SE, and less than or equal to -1.00D for corrections greater than -7.00 D SE. |
| PMA SUPPLEMENTAL APPROVALS AND PDP SUPPLEMENTAL NOTICES OF COMPLETION | |||
|---|---|---|---|
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
| D970012/S001 11/23/98 | AMS Dynaflex Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 | This device is indicated for use in the treatment of chronic, organic, male erectile dysfunction (impotence). This PDP is declared complete |
| P820076/S021
11/4/98 |
Dromos SL Pacing System | Biotronik, Inc.
Lake Oswego, OR 97035-5369 |
Approval for pacing system which includes a new single-pass VDD pacing lead, a pulse generator with high atrial sensitivity, and a new software module for use with the PMS 1000/1000C programmers. The device, as modified, will be marketed under the trade name Dromos SL Pacing System SWM 1000/F05.B00.U, and three versions of the single-pass lead, Models SL/11- BP, SL/13-BP and SL/15-BP. This pacing system is indicated for VDD pacing for patients with a healthy sinus node. |
| P830060/S043*
11/4/98 |
Models 0013 and 0015 Bipolar Endocardial Leads | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for changes to the IS-1 terminal pin for Lead Models 0013 and 0015, and minor labeling changes. |
| P840024/S076
11/19/98 |
Nucleus 22 Cochlear Implant System for Adults and Children | Cochlear Corporation
Englewood, CO 80112 |
Approval for modifications to the device to use silicone materials supplied by two new vendors. |
| P850007/S024*
11/3/98 |
Spinal-Stim® Lite Spinal Fusion System | Orthofix, Inc.
Richardson, TX 75081 |
Approval to use a smaller gauge wire for the Transducer Coil, change from PVC to Neoprene for the inside and outside covers of both front and rear Transducer coils, and slightly reduce the thickness of the Kydex material. 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. |
| P870036/S044
11/17/98 |
Medtronic® AchieverTM; Coronary Balloon Dilatation Catheter | Medtronic Interventional Vascular
San Diego, CA 92121-2256 |
Approval for a new product line. The device, as modified, will be marketed under the trade name Medtronic® AchieverTM; Coronary Balloon 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. |
| P880003/S077*
11/16/98 |
ChargerTM; PTCA Dilatation Catheters | Cordis Corporation
Miami, FL 33102-5700 |
Approval for the 18mm and 25mm length Charger PTCA catheters with 3.0mm, 3.5mm and 4.0mm balloon diameters. 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. |
| P880086/S056*
11/3/98 |
Trilogy® Family of Cardiac Pulse Generators Models
2250L/2260L/
2264L and 2308L/2318L/ 2350L/2360L/ 2364L |
St. Jude Medical
Sylmar, CA 91342 |
Approval for a change in the insulating ring surrounding the negative pin of the battery in Trilogy pacers. |
| P880091/S014
11/4/98 |
Staar Surgical Co. ElasticTM; Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens with Toric Optic, Models AA-4203T and AA-4203TF | Center for Clinical Research for Staar Surgical
Company
Elmhurst, IL 60126 |
This device is indicated for improving uncorrected visual acuity, correcting aphakia and decreasing refractive cylinder resulting from corneal astigmatism in persons aged 60 and over. |
| P890027/S045
11/19/98 |
Nucleus 22 Cochlear Implant System for Adults and Children | Cochlear Corporation
Englewood, CO 80112 |
Approval for modifications to the device to use silicone materials supplied by two new vendors. |
| P890039/S016
11/9/98 |
CCS PolySafeTM; A-Trackä Endocardial Pacing Lead Models AT-342, AT-343, AT-344, AT-442, AT-443, and AT-444 and Intermedics lead Models 425-02, 425-04 and 425-06 | Cardiac Control Systems, Inc.
Palm Coast, FL 32164 |
Approval for the use of BioSpan® MS/0.4 as a raw material for the polyurethane insulation for the above lead models. |
| P900022/S005
11/18/98 |
Chorus and Opus RM 4534 and Chorus RM 7034 Pacemakers | ELA Medical, Inc.
Plymouth, MN 55441 |
Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France. |
| P910023/S036
11/4/98 |
Ventritex® ProfileTM; II and ProfileTM; MD ICD Systems | St. Jude Medical
Sunnyvale, CA 94086-6527 |
Approval for the Ventritex® ProfileTM; II Tiered- Therapy Defibrillator System (Models V-184F and V-184HV3), ProfileTM; MD Tiered-Therapy Defibrillator System (Models V-186F and V-186HV3), Model 1500 Programmer Application Software Version 5.2, and Test Can Model AC-PFL- TCN. |
| P920015/S015
11/23/98 |
Medtronic® Models 6943 and 6945 Leads | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for a manufacturing and sterilization site located at Medtronic Puerto Rico, Inc., Villalba West Industrial Area, Villalba, Puerto Rico 00766. |
| P930016/S007
11/2/98 |
VISX STAR S2 Excimer Laser System | VISX, Inc.
Santa Clara, CA 95051 |
Approval for the VISX Excimer Laser System. This device is indicated for hyperopic PRK using an ablation zone with a correction diameter of 5.0 mm and an overall diameter of 9.0mm. |
| P930031/S005
11/30/98 |
Wallstent® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis | Schneider (USA) Inc.
Minneapolis, MN 55442 |
Approval for the UnistepTM; Plus 8 Fr delivery system. |
| P930038/S014
11/25/98 |
Angio-SealTM; Hemostatic Puncture Closure Device | Kendall Healthcare Products Company
Bothell, WA 98021 |
Approval for the addition of printed markings to the outer surface of the insertion sheath. |
| P940010/S005
11/23/98 |
Cylindrical Fiber Optic (DCYL2 Diffuser Series) | QLT Phototherapeutics, Inc.
Washington, DC 20014-1109 |
Approval for commercial distributing of the modified DCYL Cylindrical Fiber Optics which incorporate a glued diffusing tip in place of the previously approved threaded tip. The device, as modified, will be marketed under the trade name OPTIGUIDE Cylindrical Fiber Optic (DCYL2 Diffuser Series and is indicated for: palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy, and treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated. |
| P940011/S003
11/24/98 |
Coherent Lambda Plus PDL1 and PDL2 Photodynamic Lasers | Coherent Medical Group
Santa Clara, CA 95051 |
Approval to relocate manufacturing facility from Coherent, Inc., 3270 W.Bayshore Rd., Palo Alto, CA to Coherent, Inc., 2400 Condensa St., Santa Clara, CA. |
| P940015/S001
11/5/98 |
Synvisc® (hylan G-F 20) | Biomatrix, Inc.
Ridgefield, NJ 07657 |
Approval for labeling changes, including addition of the statement: "The packaging of this product contains dry natural rubber latex." |
| P950029/S003
11/18/98 |
Chorus and Opus RM 4534 and Chorus RM 7034 Pacemakers | ELA Medical, Inc.
Plymouth, MN 55441 |
Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France. |
| P950037/S005*
11/19/98 |
Kairos Family of Pulse Generators with B-G00.0.U Software | Biotronik, Inc.
Lake Oswego, OR 97035-5369 |
Approval for the Kairos family of pulse generators with B-G00.0.U Programmer Software for use with the Model 1000/1000C Programmers. As a discrete subset of the approved Actros family of pulse generators, the Kairos family is approved for the same indications. |
| P960006/S002*
11/17/98 |
SWEET TIP® Rx Active Fixation, Steroid Eluting, Endocardial pacing Leads Models 4143/4144/4145/ 4243/4244/4245 | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for a change in the IS-1 terminal connector. |
| P960018/S001
11/17/98 |
The NeedlyzerTM;
The Needle Destroyer Model ND2 |
Healthcare Products Plus, Inc.
Chicago, IL 60614 |
Approval for a change to the battery charger and the associated instructions for use. |
| P960057/S002*
11/25/98 |
ADCON®-L Adhesion Control in a Barrier Gel | Gliatech, Inc.
Cleveland, OH 44122 |
Approval for a change in ADCON-L kit packaging configuration, i.e., replacing the aluminum tube with a polypropylene syringe, and replacing the PVC application with a polypropylene applicator. |
| P970004/S003
11/2/98 |
Medtronic® Interstim® Continence Control System
(Medtronic® Model 3057 Test Stimulation Lead Bulk Accessory/
Medtronic® Model 3065U Test Stimulation Lead Kit) |
Medtronic, Inc.
Minneapolis, MN 55440-9087 |
Approval for marketing the Medtronic® Model 3057 Test Stimulation Lead Bulk Accessory/ Medtronic® Model 3065U Test Stimulation Lead Kit for use with the Medtronic® Interstim® Continence Control System which is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. |
| P970012/S002
11/19/98 |
Medtronic.Kappa 400 Pacemakers | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for ICD compatibility labeling for the Medtronic.Kappa 400 pacemaker. |
| P970019/S003
11/18/98 |
LithoTronTM; | HealthTronics, Inc.
Marietta, GA 30067 |
Approval for modifications to the LithoTronTM; Lithotripsy System's labeling to reflect the results of this 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 this postapproval requirement is now considered complete. |
| P970019/S005*
11/17/98 |
LithoTronTM; Lithotripsy System | HealthTronics, Inc.
Marietta, GA 30067 |
Approval for use of a new patient table model with the LithoTronTM; Lithotripsy System, with associated labeling changes. |
| P970020/S003
11/24/98 |
ACS RX Multi-Link HPTM; and ACS OTW Multi-Link HPTM; Coronary Stent Systems | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for a change in the Mean Stent Compliance Outer Diameter specification, associated with the ACS RX Multi-Link HPTM; and ACS OTW Multi-Link HPTM; Coronary Stents Systems. |
| P970020/S004
11/5/98 |
ACS Multi-Link RX DuetTM; and ACS Multi-Link OTW DuetTM; Coronary Stent Systems | Guidant Corporation/
Advanced Cardiovascular Systems Santa Clara, CA 95052 |
Approval for the ACS Multi-Link RX DuetTM; and ACS Multi-Link OTW DuetTM; Coronary Stent Systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic lesions in native coronary arteries (length <25mm) with a reference vessel diameter ranging from 3.0 mm to 4.0 mm. |
| P970051/S003
11/19/98 |
Nucleus 24 Cochlear Implant System for Adults and Chilren | Cochlear Corporation
Englewood, CO 80112 |
Approval for modifications to the device to use silicone materials supplied by two new vendors. |
*Evaluated as a "Real-Time Review" PMA Supplement.
| 30-DAY NOTICES | |||
|---|---|---|---|
| APPLICATION NUMBER LTR DATE |
DEVICE NAME |
COMPANY NAME | COMMENTS |
| P790018/S034**
11/16/98 |
MedtronicTM; Prosthetic Heart Valve | Medtronic
Minneapolis, MN 55440 |
The 30-day notice requested a change in the supplier of a raw material (yarn) for the device because the current supplier of Polytetrafluoro-ethylene (PTFE) yarn has chosen to withdraw this material from the implantable medical device industry. |
| P970020/S006**
11/10/98 |
ACS RX MULTI-LINKTM; Coronary Stent System ACS RX MULTI-LINK HPTM; Coronary Stent System | Guidant Corporation
Temecula, CA 92591-4628 |
The 30-day Notice requested that FDA review a change in the manufacturing process, removing the C-flex Junction Shear Strength Test, a design verification test, from production testing of the ACS RX MULTI-LINKTM; Coronary Stent System and the ACS RX MULTI-LINK HPTM; Coronary Stent System. |
| P970034/S001**
11/20/98 |
UVA-PMMA Posterior Chamber Intraocular Lenses | Ophthalmic Innovations International, Inc.
Claremont, CA 91711 |
The 30-day Notice requested approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chamber at Griffith MicroScience, the same sterilization contractor approved in the firm's original PMA. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times. |
| P970035/S009**
11/17/98 |
Micro Stent II Over-the-Wire Coronary Stent System GFX Over-the-Wire Coronary Stent System | Arterial Vascular Engineering
Santa Rosa, CA 95403 |
The 30-day Notice requested a change in the current Thermal Transfer Printing on the Strain Relief to Ink Jet Printing on the Proximal Two-arm Luer Adapter. |
| P970035/S010**
11/17/98 |
Micro Stent II Over-the-Wire Coronary Stent System GFX Over-the-Wire Coronary Stent System | Arterial Vascular Engineering
Santa Rosa, CA 95403 |
The 30-day Notice requested a change in the current Secure Strain Relief Process temperature from 300 degrees F to 260 degrees F in order to optimize the process. |
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 31
Summary of PMA Originals Under Review
Total Under Review: 62
Total Active: 22
Total On Hold: 40
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 194
Total Active: 131
Total On Hold: 61
Number Greater Than 180 Days: 2
Summary of All PMA Submissions Received
Originals: 0
Supplements: 27
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 31
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 134.8
Number Greater Than 180 Days: 2
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