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PMA Final Decisions Rendered for December 1999 |
 |
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 |
|
12/16/99 |
Dishler Excimer Laser System |
Laser Institute of the Rockies Englewood, CO 80111 |
Approval for LASIK in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from -0.5 to -13.0 diopters (D) MRSE (manifest refraction spherical equivalence) with or without -0.5 D to - 4.0 D astigmatism; and in patients with documented evidence of changes in manifest refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of preoperative examination. |
|
12/8/99 |
FloSeal® Matrix, FloSeal Matrix Hemostatic Sealant, Proceed® Hemostatic Sealant |
Fusion Medical Technologies, Inc. Mountain View, CA 94043 |
The device is indicated in surgical procedures (other than in neurosurgical, ophthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
|
12/3/99 |
Model 4170 BLU-U TM |
Guidelines, Inc. Miramar, CA 33025 |
The device is indicated for use in Photodynamic Therapy with Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp. |
| PMA Supplemental Approvals | |||
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION / INDICATIONS |
|
N13787/S003 12/10/99 |
ENUCLENE® Ophthalmic Solution |
Alcon Laboratories, Inc. Fort Worth, TX 76134-2099 |
Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134. |
|
N50510/S096 12/10/99 |
Vitek® 2 Gram Negative Susceptibility Test for Piperacillin |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic piperacillin at concentrations of 4, 16 and 64m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to piperacillin in the range of £ 4 to ³ 128m g/ml. |
|
N50510/S097 12/3/99 |
Vitek® 2 Gram Negative Susceptibility Test for ampicillin/ sulbactam |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic ampicillin/ sulbactam at concentrations of 4/2, 16/8, 32/16m g/ml to the Vitek®2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ampicillin/ sulbactam in the range of £ 2/1 to ³ 32/16m g/ml. |
|
N50510/S101 12/10/99 |
Vitek® 2 Gram Positive Susceptibility Test for Erythromycin |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic erythromycin at concentrations of 0.25, 0.5, and 2m g/ml to the Vitek® 2 Gram Positive Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive isolates to erythromycin in the range of £ 0.25 to ³ 8m g/ml. |
|
N50510/S102 12/10/99 |
Vitek® 2 Gram Positive Susceptibility Test for Ciprofloxacin |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic ciprofloxacin at concentrations of 1, 2 and 4 m g/ml to the Vitek® 2 Gram Positive Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organism to ciprofloxacin in the range of £ 0.5 to ³ 8m g/ml. |
|
P780007/S042 12/14/99 |
BIOMEDICS 38 (polymacon) hydrophilic contact lenses |
Ocular Sciences, Inc. Rockville, MD 20852 |
Approval for a new manufacturing facility located at Ocular Sciences/American Hydron, Juana Diaz Industrial Park, 500 Road 531, Juana Diaz, Puerto Rico. |
|
P790002/S021 12/29/99 |
EBI Bone Healing System Model 1026 |
EBI Electro Biology Parsippany, NJ 07054 |
Seven modifications to the Model 1026. Addition of components to the Printed wiring board, addition of a ferrite sleeve, change in the control unit and labeling changes. |
|
P810031/S022 12/21/99 |
Healon® Sodium Hyaluronate |
Pharmacia & Upjohn Kalamazoo, MI 49001-0199 |
Approval for a modification to the final product release testing requirements for the family of Healon® Sodium Hyaluronate viscoelastic products. |
|
P810055/S069 12/3/99 |
Ultraviolet (UV) Absorbing Polymethylmethacrylate (PMMA) Posterior Chamber Intraocular Lens |
Pharmacia & Upjohn Pickerington, OH 43147 |
Approval for the use of UVEX 326 polymethylmethacrylate (PMMA) material in the manufacture of one-piece PMMA posterior chamber intraocular lenses (IOLs) approved under P810055. |
|
P830026/S077 12/2/99 |
Pacemakers and Pacemaker Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798. |
|
P840024/S079* 12/23/99 |
Nucleus 22 Cochlear Implant System for Adults and Children – ESPrit 22 Speech Processor |
Cochlear Corp. Englewood, CO 80112 |
Approval for the ESPrit 22 Speech Processor. |
|
P850020/S012 12/17/99 |
Prosorba® Column |
Cypress Bioscience, Inc. San Diego, CA 92121 |
Approval of post-approval study protocols. |
|
P860007/S021 12/2/99 |
Pacemakers and Pacemaker Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798. |
|
P890003/S058* 12/27/99 |
Medtronic Reveal® Plus ® Insertable Loop Recorder Software Model 9809E |
Medtronic, Inc. Shoreview, MN 55126
|
The device is indicated for the programming of the adjustable parameters of the implantable recorder used in the device. |
|
P890023/S009 12/14/99 |
BIOMEDICS 55 (ocufilcon D) hydrophilic contact lenses |
Ocular Sciences, Inc. Rockville, MD 20852 |
Approval for a new manufacturing facility located at Ocular Sciences/American Hydron, Juana Diaz Industrial Park, 500 Road 531, Juana Diaz, Puerto Rico. |
|
P890027/S048* 12/23/99 |
Nucleus 22 Cochlear Implant System for Adults and Children – ESPrit 22 Speech Processor |
Cochlear Corp. Englewood, CO 80112 |
Approval for the ESPrit 22 Speech Processor. |
|
P890055/S008 12/10/99 |
Flex Tip Plus Intraspinal Catheter Kit catalog #AP-07009 |
Arrow International Walpole, MA 02081 |
Approval for the following modifications of the existing Flex Tip Plus Intraspinal Catheter Kit catalog #AP-07008: 1) Addition of a "locking feature" to the current catheter connector design to prevent the connector from being inadvertently opened. 2) Addition of a "stylet" to the kit. 3) Replacement of the blunt flushing needle with the "Snap Lock Flushing Adapter". 4) Addition of the "threading guide" and the "attachable wing hub". 5) Increasing the Flex Tip Plus Intraspinal Catheter length. |
|
P900056/S030# 12/2/99 |
Rotablator® Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052-3376 |
Approval for modifications to existing related quality assurance inspections, manufacturing changes, and labeling changes, which are being implemented to correct a brake mechanism failure problem. |
|
P900056/S031 12/2/99 |
Rotablator® Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052-3376 |
Approval for manufacturing and design modifications, which are being implemented to correct a brake mechanism failure problem. |
|
P900061/S036 12/2/99 |
Medtronic® Model 7227 GEM® Implantable Cardioverter Defibrillator with Connector Configuration Modules 5227B, 5227D and 5227E |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for the Medtronic® Model 7227 GEM® Implantable Cardioverter Defibrillator with Connector Configuration Modules 5227B, 5227D, and 5227E. |
|
P910001/S016 12/10/99 |
Spectranetics CVX-300® Excimer Laser System |
Spectranetics Corporation Colorado Springs, CO 80907-5186 |
Approval for software modifications for the Power Error audible tone warning and Fault 10 display features. |
|
P910020/S024 12/2/99 |
Pacemakers and Pacemaker Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798. |
|
P910056/S007* 12/16/99 |
SOFLEX UV-Absorbing Silicone Posterior Chamber Intraocular Lens Model LI63U |
Bausch & Lomb Surgical Claremont, CA 91711 |
Approval for Model LI63U and to use MED-6812SH silicone material as an alternative to RMX-3 silicone for models with polyimide haptics approved under this PMA. |
|
12/16/99 |
SpinaLogic 1000 Bone Growth Stimulator |
Orthologic Corp. Tempe, AZ 85281 |
Change to the indications for use and will be marked under the tradename SpinaLogic 1000 Bone Growth Stimulator |
|
P920014/S001 12/16/99 |
Heartmate® IP LVAS |
Thermo Cardiosystems, Inc. Woburn, MA 01888-2697 |
Approval to use Cardioflex® instead of Biomer for manufacturing the diaphragms for the device. The device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. |
|
P920014/S010* 12/10/99 |
HeartMate® IP and VE LVAS |
Thermo Cardiosystems, Inc. Woburn, MA 01888-2697 |
Approval to introduce self-locking screw rings to attach the pump elbows to the two valved conduits and the outflow valved conduit to the outflow graft. |
|
P930038/S020 12/8/99 |
Angio-Seal® Hemostatic Puncture Closure Device |
Daig Corporation Minnetonka, MN 55345-2126 |
Approval for the alternate manufacturing facility located at the Daig Corporation, 14901 DeVeau Place, Minnetonka, MN 55345. |
|
P940008/S014 12/2/99 |
Pacemakers and Pacemaker Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798. |
|
P940015/S003 12/20/99 |
Synvisc® hylan G-F 20 |
Biomatrix, Inc. Ridgefield, NJ 07657 |
Approval for a labeling change in the Physician Package Insert to reflect information in the Patient Package Insert regarding the time of maximum treatment effect. |
|
P940022/S007 12/23/99 |
CLARION® Multi-Strategy Cochlear Implant (Adult) Electrode Positioner |
Advanced Bionics Corp. Sylmar, CA 91342 |
Approval for the CLARION® Multi-Strategy Cochlear Implant (Adult) Electrode Positioner. |
|
P950002/S008* 12/20/99 |
BAK Interbody Fusion System |
Sulzer Spine-Tech Minneapolis, MN 55439-2027 |
Approval for the additional sizes to the BAK product line. |
|
P950019/S010 12/1/99 |
Ray Threaded Fusion Cage with Instrumentation |
United States Surgical Surgical Dynamics, Inc. Norwalk, CT 06856 |
Approval for the Sulzer Spine-Tech facility located at 8990 Springbrook Drive, #10, Minneapolis, MN 55433 as an alternate site for assembly, packaging and quality control of the device and the BioTest Laboratories, Inc., located at 7375 Bush Lake Rd., Minneapolis, MN 55439 as an alternate site for assembly, packaging and labeling of the device. |
|
P950027/S002 12/18/99 |
Hyalgan® |
Fidia Pharmaceutical Corporation Washington, D.C. 20006 |
Approval for modification of labeling to be modified and to add the information about the current clinical experience of the device as detailed in the amendment of 12/10/99. |
|
P950027/S003 12/18/99 |
Hyalgan® |
Fidia Pharmaceutical Corporation Washington, D.C. 20006 |
Approval for modification of labeling to be modified and to add the information about the current clinical experience of the device as detailed in the amendment of 12/10/99. |
|
P950029/S008 12/3/99 |
Multi-Partition Operating Environment (MOE) |
ELA Medical, Inc. Plymouth, MN 55441 |
Approval for the Multi-Partition Operating Environment to be used on ELA Medical programmers. |
|
P960004/S009 12/2/99 |
Pacemakers and Pacemaker Leads |
Guidant Corp. St. Paul, MN 55112-5798 |
Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798. |
|
P960009/S008 12/17/99 |
Activa Tremor Control Therapy System |
Medtronic, Inc. Minneapolis, MN 55421 |
Approval for a manufacturing site located at Medtronic Puerto Rico, Villalba, Puerto Rico. The percutaneous extension accessory device (Part #502644-TAB) will be manufactured at this facility. |
|
P960016/S003 12/13/99 |
Livewire TC® Cardiac Ablation System |
DAIG Corporation Minnetonka, MN 55345-2126 |
Approval for a change in sterilization process from 12% EtO/88% CFC to 100% * * EtO (while at the same time transferring the sterilization to an outside contract sterilization facility). |
|
P960028/S005* 12/9/99 |
ARRAY® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL) |
Allergan, Inc. Irvine, CA 92612-9534 |
Approval for expansion of the diopter range from 10-30D to 6-30D. |
|
P960054/S002 12/7/99 |
S-ROM Poly Dial® Constrained Acetabular Liner |
DePuy Orthopedics, Inc. Warasaw, IN 46581-0988 |
Approval for a design modification made to the S-ROM constrained liner so to be used with the DePuy Duraloc and Solution Acetabular Cup Systems. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. |
|
P960054/S003 12/22/99 |
S-ROM® Poly-Dial Constrained Liner |
DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988 |
Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England. |
|
P970003/S024# 12/18/99 |
Model 400 NCP Tunneling Tool |
Cyberonics, Inc. Houston, TX 77058 |
Approval for labeling changes to enhance the safety of Model 400 NCP Tunneling Tool. |
|
P970008/S012 12/4/99 |
Urologix Targis® System |
Urologix, Inc. Minneapolis, MN 55447 |
Approval for modifying the contraindications regarding use in patients with implants. |
|
P970012/S009* 12/23/99 |
Medtronic Vision software Model 9952/9952A series 3.0 and Model 9953/9953A series 3.0 |
Medtronic, Inc. Shoreview, MN 55126-2983 |
Approval for the Medtronic Vision software Model 9952/9952A series 3.0 (to program the Medtronic Kappa 400/DX2 devices) and the Medtronic Vision software Model 9953/9953A series 3.0 (to program the Medtronic Kappa 700/600 devices). The devices are indicated for use with the Medtronic Model 9790 and Model 9790C Programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry. |
|
P970019/S006 12/17/99 |
HealthTronics LithoTron® Lithotripsy System LithoTron ULS® Ultrasonic Stone Localization Accessory |
HealthTronics, inc. Marietta, GA 30067 |
Approval for addition of an ultrasonic stone location accessory. The device is indicated for preliminary localization of a target stone prior to extracorporeal shock wave lithotripsy with the Lithotron® Lithotripsy System. The indications for use have not changed. |
|
P970020/S017 12/22/99 |
ACS Multi-Link RX and OTW Tristar® Coronary Stent Systems |
Guidant Corporation Santa Clara, CA 95052 |
Approval for the ACS Multi-Link RX and OTW Tristar® Coronary Stent Systems. |
|
P970043/S002 12/3/99 |
LADARVision® Excimer Laser System for Photorefractive Keratectomy (PRK) |
Autonomous Technologies Corporation Orlando, FL 32826 |
Approval to modify the current labeling by 1)updating the clinical results with 12-month data; 2)presenting the 12-month data stratified into three groups (low myopia, low myopia with astigmatism, and high myopia with and without astigmatism) based on preoperative refractive error, and 3) including new contrast sensitivity claims based on a contrast sensitivity study of 284 pts. Other modifications to the labeling include editorial changes, the addition of new data tables reformatted to reflect the revised stratification of data, and the inclusion of a revised contrast sensitivity labeling statement to read: "In a contrast sensitivity study designed to assess the effects of LADARVision surgery on how well patients can see in conditions such as very dim light, rain, snow, fog or glare from bright lights at night, the percentages of patients showing clinically significant losses were 10.6% at 6 months and 6.6% at 12 months after surgery, and the percentages of patients showing clinically significant improvements were 5.9% at 6 months and 3.3% at 12 months after surgery." |
|
P970051/S009* 12/23/99 |
Nucleus 24 Cochlear Implant System for Adults and Children – Sprint Long Range Coil |
Cochlear Corp. Englewood, CO 80112 |
Approval for the SPrint Long Range Coil. |
|
P980012/S001 12/21/99 |
Novacor LVAS |
Baxter Healthcare Corporation Oakland, CA 94621 |
Approval to introduce the Novacor LVAS Compact Controllers with AutoTuning Software. |
|
P980016/S010* 12/23/99 |
Medtronic® Model 7271 GEM® DR Implantable Cardioverter Defibrillator |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for low power hybrid circuitry changes which will improve the patient alert drive transistors, the charge pump circuit and the manufacturing process. |
|
P980016/S012* 12/13/99 |
Medtronic® Models 7273 and 7229 Implantable Cardioverter Defibrillators |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for modifications to the circuitry of the Medtronic® Models 7273 and 7229 Implantable Cardioverter Defibrillators. |
|
P980035/S004* 12/9/99 |
Medtronic Model 350 Series Pacing System |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for the Medtronic Model 350 Series Pacing System Programmed by the Medtronic Model 9790/C Programmer with Sigma Model 9963/9963A software. |
|
P980035/S005* 12/23/99 |
Medtronic Vision software model 9952/9952A series 3.0 and Model 9953/9953A series 3.0 |
Medtronic, Inc. Shoreview, MN 55126-2983 |
Approval for the Medtronic Vision software Model 9952/9952A series 3.0 (to program the Medtronic Kappa 400/DX2 devices) and the Medtronic Vision software Model 9953/9953A series 3.0 (to program the Medtronic Kappa 700/600 devices). The devices are indicated for use with the Medtronic Model 9790 and Model 9790C Programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry. |
|
P980035/S006# 12/20/99 |
Medtronic.Kappa Model KDR 721 Pacemaker |
Medtronic, Inc. Minneapolis, MN 55126-2983 |
Approval for a correction to the shipping box label for the Model KDR 721 pacemaker properly identifying the contents as a "Dual Chamber Rate Responsive Pacemaker." |
|
P990004/S001* 12/2/99 |
SURGIFOAM® Absorbable Gelatin Sponge, USP |
Ethicon, Inc. Somerville, NJ 08876-0151 |
Approval for the addition of sponges 3mm and 7mm thick. |
| 30-Day Notices (***135 Day Supplement was not required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
COMMENTS |
|
P970035/S018*** 12/22/99 |
S540 Over The Wire Coronary Stent System |
Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403 |
Manufacturing changes to the inner member necking process |
|
P970020/S019*** 12/22/99 |
ACS Multi-Link Rx Duet/OTW Duet Coronary |
Guidant Corp. Temecula, CA 92591 |
Addition of on-line inspection step for various lengths and diameters of the ACS MULTI-LINK® DUET RX and OTW Coronary Stent Systems |
|
P990020/S001*** 12/10/99 |
The AneuRx® Stent Graft System |
Medtronic AVE Santa Rosa, CA 95407 |
The 30-Day Notice requested a change to add a supplier of expanded stents. |
*Real-Time Supplement
**135 Day Supplement
***30 Day Notice (135 Day Supplement Was Not Required)
# "Special – Changes Being Effected"
# Panel-Track Supplement
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 55
Summary of PMA Originals Under Review
Total Under Review (Pending): 103
Total Active: 51
Total On Hold: 52
Number Under Review and Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review (Pending): 218
Total Active: 148
Total On Hold: 70
Number Under Review and Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 6
Supplements: 39
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 55
Average Days Fr Receipt to Decision (Total Elapsed Time in Days):
FDA: 102.0
Manufacturer: 63.6
Total: 165.6
Updated 2/5/2001
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