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PMA Final Decisions Rendered for June 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 |
|---|---|---|---|
| P970040
6/26/98
|
Achilles+Bone Sonometer | Lunar
Madison, Wisconsin 53713 |
The device is indicated as follows: The Achilles+ ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness Index results expressed as T-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are T-scores or obtained by X-ray absorpiometry. Either the Stiffness Index T-score or X-ray absorptiometry T-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The Stiffness Index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes. |
| P970051
6/25/98 |
Nucleus 24 Cochlear Implant System | Cochlear Corporation
Englewood, CO 80112 |
Intended to restore a level of auditory sensation to adults and children via electrical stimulation of the auditory nerve. |
| P970058
6/26/98 |
M1000 Image Checker | R2 Technology, Inc.
Washington, D.C. 20004 |
The device is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiolosist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review. |
| P970062
6/24/98 |
Genestone 190 Lithotripter | BMT, Inc.
Woodbury, CT 06798 |
This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size. |
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE |
COMPANY NAME |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P810046/S185
6/8/98 |
ACS RX Comet VP™ Coronary Dilatation Catheters with HYDROCOAT™ Hydrophilic Coating | Guidant Corporation
Santa Clara, CA 95052 |
Approval for an additional balloon length, the addition of HYDROCOAT™ hydrophilic coating, a change in the sterilization method and packaging and an increase in the rated burst pressure for the 3.25mm through 4.0mm balloon diameters. The device as modified, will be marketed under the trade name ACS RX Comet VP™ Coronary Dilatation Catheters with HYDROCOAT™ Hydrophilic coating and is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST- segment elevation myocardial infarction. |
| P810046/S188
6/29/98 |
ACS RX ROCKET™ Coronary Dilatation Catheter | Guidant Corporation
Santa Clara, CA 95052-8167 |
Approval for the addition of two quality control tests to the manufacturing process of the ACS RX ROCKET™ Coronary dilatation Catheter. |
| P840008/S063 | HM3, HM4, MFL 5000, MPL 9000, and Dornier Lithotripter Transportable | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
Approval for revision of labeling regarding: 1) the risk of hypertension following renal lithotripsy, consistent with the conclusions of final postapproval study report (all models) 2) the maximum patient weight to be treated (HM4); and 3) additional safe treatment practices regarding non-ECG gated treatment (MFL 5000). |
| P840008/S064*
6/5/98 |
Dornier Lithotripter (Stationary, Mobile, and Transportable Models) | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
Approval for changes to the therapy head positioning, modifications of the control panel, addition of a servicing modem, changes to the air flow within the device, material changes to the patient table, ECG monitor model replacement, change of the available X-ray features, software modifications, labeling changes, and integration of the water circulation device with its control computer. The device, as modified, will be marketed under the trade name Dorneir Lithotripter S and is indicated for the fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones. |
| P840024/S071
6/21/98 |
Nucleus 22 Channel Cochlear Implant System | Cochlear Corporation
Englewood, CO 80112 |
Approval for a new sterilization facility located at Cochlear Limited, 14 Mars Road, Lane Cove, New South Wales 2066, Australia. |
| P840024/S072
6/26/98 |
Nucleus 22 Channel Cochlear Implant System for Adults and Children | Cochlear Corporation
Englewood, CO 80112 |
Approval for modifications to your device to allow the patient to undergo Magnetic Resonance Imaging (MRI). |
| P840064/S021
6/29/98 |
Viscoat® Viscoelastic Solution | Alcon Laboratories, Inc.
Fort Worth, TX 76134 |
Approval for the addition of a cannula locking ring to the currently marketed delivery system for VISCOAT®. |
| P850089/S038
6/1/98 |
CapSure® Z Novus™ Models 5054 and 5554 and CapSure® SP Novus™ Models 5092 and 5592 Transvenous Tined Pacing Leads | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for the addition of four transvenous leads to the CapSure® product line. The device, will be marketed under the trade names CapSure® Z Novus Models 5054 and 5554 and CapSure® SP Novus Models 5092 and 5592 and are indicated for pacing and sensing in the atrium or ventricle where implantable atrial or ventricular, single-chamber or dual- chamber pacing systems are indicated. |
|
P860019/S131 6/29/98 |
SCIMED® COYOTE™ Percutaneous Transluminal Angioplasty Coronary (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a modification of the SCIMED Ranger™ PTCA Catheter, with the primary difference being use of a new balloon material. The device, as modified, will be marketed under the trade name SCIMED® COYOTE™ Percutaneous Transluminal Angioplasty Coronary (PTCA) Catheter and is indicated for the balloon dilatation of coronary arteries or bypass graft stenosis for the purpose of improving myocardial perfusion and (balloon models 2.5-4.0 mm only) the post-delivery expansion of balloon expandable stents. |
| P870049/S027
6/30/98 |
MicroScan® Rapid Flourogenic Panels | Dade MicroScan, Inc.
West Sacramento, CA 95691 |
Approval for the addition of a limitation to use an alternative method to confirm results for the testing of Staphylococcus spp. with the antibiotic Vancomycin. The device, as modified, will be marketed under the trade name MicroScan® Rapid Fluorogenic. |
| P880003/S072
6/3/98 |
Cordis Charger™ PTCA Dilatation Catheters | Cordis Corporation
Miami Lakes, FL 33014 |
Approval for an additional marker band on the 10 mm balloon length of the Cordis Charger™ PTCA Dilatation Catheters. |
| P880027/S055
6/15/98 |
Takumi™ Over the Wire PTCA Catheters | Schneider (USA), Inc.
Minneapolis, MN 55442 |
Approval for a modified package label, removing specification of the deflated profile. |
| P890003/S050
6/3/98 |
Medtronic Models 5038-58, 5038-65, 5038S-52, 5038S-58 and 5038L-65 CapSure VDD-2 and Vitatron Models IMW 14Q/15Q/16Q/17Q/18Q Brilliant S+ VDD Pacing Leads | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: Medtronic Models 5038-58, 5038-65, 5038-52, 5038S-58, and 5038L-65 CapSure VDd-2 and Vitatron Models IMW 14Q/15Q/16Q/17Q/18Q Brilliant S+ VDD Pacing Leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current Medtronic® VDD pacemakers. |
| P890027/S040
6/26/98 |
Nucleus 22 Channel Cochlear Implant System | Cochlear Corporation
Englewood, CO 80112 |
Approval for a new sterilization facility located at Cochlear Limited, 14 Mars Road, Lane Cove, New South Wales 2066, Australia. |
| P890027/S041
6/26/98 |
Nucleus 22 Channel Cochlear Implant System for Adults and Children | Cochlear Corporation
Englewood, CO 80112 |
Approval for modifications to your device to allow the patient to undergo Magnetic Resonance Imaging (MRI). |
| P890043/S032*
6/8/98 |
Simpson Coronary AtheroCath™ | Guidant Corporation
Temecula, CA 92591-4628 |
Approval for a change in the biological indicator incubation time from 7 to 5 days. |
| P890057/S010
6/15/98 |
Model 3100A High Frequency Oscillatory Ventilator | SensorMedics Corporation
Yorba Linda, CA 92887-4645 |
Approval for changes to the oscillating mechanism and an increased range of continuous flow. |
| P900043/S008
6/8/98 |
PALMAZ-SCHATZ™ Balloon Expandable Stent with 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 include addition of the Stars Trial results to the clinical summary section. |
| P900043/S009
6/24/98 |
PALMAZ-SCHATZ™ Balloon Expandable Stent | Cordis Corporation
Warren, NJ 070959 |
Approval for addition of the patient manual titled "Understanding Coronary Artery Disease and your Stent: A Guide for Patients." |
| P900043/S011
6/29/98 |
PALMAZ-SCHATZ™ Balloon Crown Balloon Expandable Stent with Powergrip™ Over-the-Wire Delivery System | Cordis Corporation
Warren, NJ 07059 |
Approval for a redesigned taper tip configuration of the Power Grip™ Delivery System. The modification results in an increase in tip length from 5 mm to 7 mm and a decrease in tip inner diameter from 0.020" to 0.016."| |
|
P910066/S008 6/12/98 |
Orthologic™ 1000 and CC Bone Growth Stimulator | Orthologic Corporation
Tempe, AZ 85281 |
Approval for a change in the indications for use language to state "The Orthologic 1000 Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site show no visibly progressive sign s of healing"; and "The Orthologic CC Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing." |
| P910067/S003*
6/4/98 |
SVS Apex Plus Excimer Laser Workstation | Summit Technology, Inc.
Waltham, MA 02154 |
Approval for an external chiller option for the SVS Apex Plus Excimer Laser System. |
| P920004/S009
6/12/98 |
VasoSeal® Vascular Hemostasis Device | Datascope Corporation
Montvale, NJ 07645 |
Approval for modifying the precautions section of the VasoSeal® Instructions for Use regarding repuncture of a previously treated VasoSeal® site. |
| P930012/S010*
6/15/98 |
Champion™ NC PTCA Catheter and Wrap™ NC PTCA Catheter Product Lines | United States Surgical Corp.
Norwalk, CT 06856 |
Approval for 1) a change in trade names for the Champion™ HP PTCA Catheters and Champion™ HP PTCA Catheters with Wrap™ Sheathing System previously approved under PMA supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3.5 mm and 4.0 mm diameter balloons used in these designs. The devices, as modified, will be marketed under the trade names Champion™ NC PTCA Catheter and Wrap™ NC PTCA Catheter, and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P930034/S011*
6/4/98 |
SVS Apex Plus Excimer Laser Workstation | Summit Technology, Inc.
Waltham, MA 02154 |
Approval for an external chiller option for the SVS Apex Plus Excimer Laser System. |
| P930038/S010
6/3/98 |
Angio-Seal™ Hemostatic Puncture Closure Device | Quinton Instrument Company
Bothell, WA 98021-8906 |
Approval for changes in the Instructions for Use to include a secondary manual tamp during deployment of the device. |
| P930038/S012
6/16/98 |
Angio-Seal™ Hemostatic Puncture Closure Device | Sherwood Davis & Geck
Bothell, WA 98021-8906 |
Approval for changes in the design of the anchor and collagen sponge components of the Angio-Seal™ device. |
| P930039/S004
6/3/98 |
SureFix™ Model 5072 Pacing Lead | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for the SureFix™ Model 5072 Steroid-Eluting Screw-In Pacing Lead with a Non-Retractable Helix. The device, as modified, will be marketed under the trade name SureFix™ Model 5072 Pacing Lead and is designed to be used with a pulse generator as part of a cardiac pacing system. The lead has application where implantable atrial or ventricular, single chamber or dual chamber pacing systems are indicated. |
| P950014/S014*
6/9/98 |
Prostatron™ | EDAP Technomed, Inc.
Burlington, MA 01803 |
Approval for an upgrade to the Prostatron's™ operating software to Prostasoft 4.0 (also referred to as "Prostasoft 98"). |
| P950019/S002*
6/8/98 |
Ray Threaded Fusion Cage (TFC)™ with instrumentation | United States Surgical Corporation
Norwalk, CT 06856 |
Approval for additional instruments and a change to the surgical technique manual. |
| P950019/S003
6/17/98 |
Ray Threaded Fusion Cage (TFC)™ with instrumentation | United States Surgical Corporation
Norwalk, CT 06856 |
Approval for the addition of 20mm cages and modified labeling. |
| P960013/S002
6/15/98 |
Locator™ Steerable Stylet Model 4036 | St. Jude Medical
Sylmar, CA 91342 |
Approval for the Locator™ Steerable Stylet Model 4036. |
| P960042/S001
6/16/98 |
12 French Outer Sheath | Spectranetics Corporation
Colorado Springs, CO 80907-5159 |
Approval for the 12 French Outer Sheath. The device is an accessory to the 12 French Laser Sheath and will be packaged in the 12 French Laser Sheath Kit. |
| P960053/S001
6/4/98 |
Braun-Cutter Trapezo-Metacarpal Prosthesis | Avanta Orthopedics
San Diego, CA 92121 |
Approval for 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels. |
P960053/S002 6/4/98 |
Braun-Cutter Trapezo-Metacarpal Prosthesis |
Avanta Orthopedics San Diego, CA 92121 |
Approval for 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels. |
| P960058/S002
6/22/98 |
CLARION® Multi-Strategy Cochlear Implant (Pediatric) | Advanced Bionics Corporation
Sylmar, CA 91342 |
Approval for Postmarket Language study. |
| P970031/S003
6/16/98 |
FREESTYLE® Aortic Root Bioprosthesis | Medtronic Cardiac Surgery
Minneapolis, MN 55440 |
Approval for the patient brochure for the device. |
| P970044/S001*
6/23/98 |
Urowave® Microwave Thermotherapy System | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
Approval for the removal of the External Interstitial Thermometry System from the Urowave®. |
*Evaluated as a "Real-Time Review" PMA Supplement.
| APPLICATION NUMBER & LTR DATE | DEVICE NAME | COMPANY NAME | COMMENTS |
| P900060/S017**
6/11/98 |
Carbomedics Prosthetic Heart Valve Sulzer Carbomedics Carbo-Seal Ascending Aortic Prosthesis |
Sulzer Carbomedics, Inc.
Austin, TX 78752-1793 |
Requested a modification in the type of biological indicator used in the sterility release of the Carbo-Seal AAP from the AMSCO Spordex Bacillus Subtilis globigii spore strips to the 3M Healthcare Attest Bacillus subtilis globigii self-contained biological indicator. The stated reason for the change is to reduce the incubation period from seven to two days, and to reduce the change of operator error by eliminating the possibility of contamination that may occur when spore strips in glassine envelopes are transferred to growth medium. |
**A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 39
Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 42
Total On Hold: 31
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 230
Total Active: 145
Total On Hold: 82
Number Greater Than 180 Days: 10
Summary of All PMA Submissions Received
Originals: 5
Supplements: 57
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 39
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 141.2
Number Greater Than 180 Days: 10
Updated 10/7/1998
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