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PMA Final Decisions Rendered for April 1997 |
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 |
---|---|---|---|
P950043
4/7/97 |
Econolith Extracorporeal Shock Wave Lithotripter | Medispec, Ltd. (USA)
Rockville, MD 20850 |
Indicated for use in the non-invasive fragmentation of upper urinary tract stones between 5 and 20mm in size. |
P960039
4/17/97 |
Soft-55 EW Aphakic (vifilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear | Biocompatibles, Inc.
Norfolk, VA 23507 |
Indicated for extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. The lenses are indicated for the correction of visual acuity in aphakic persons (after cataract surgery) that are myopic or hyperopic. Soft-55 EW Aphakic lenses may be worn by persons who may exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. |
P960043
4/30/97 |
Prostar® Percutaneous Vascular Surgical (PVS) System | Perclose, Inc.
Menlo Park, CA 94025 |
The Prostar® PVS System consists of the Prostar® PVS Device (9 and 11 French sizes) and the following accessories: a Prostar® Pre-Dilator (9 and 11 French sizes), a Perclose® Knot Pusher, and Prostar® Transition Guidewire, and a Perclose® Arterial Tamper. The Prostar® PVS System is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (time-to-standing) of patients who have undergone interventional procedures using 8 to 11 French sheaths. |
APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
---|---|---|---|
N50510/S075
4/24/97 |
Vitek Systems "General Susceptibility Card" | bioMerieux Vitek, Inc.
Hazelwood, MO 63042-2395 |
Approval for Sparfloxacin to be included on the Gram Positive Susceptibility Card in three concentrations (equivalent to 0.5, 1 and 2 g/ml). |
N50510/S077
4/24/97 |
Vitek Systems "General Susceptibility Card" | bioMerieux Vitek, Inc.
Hazelwood, MO 63042-2395 |
Approval for Lomefloxacin to be included on the Gram Positive Susceptibility Card in three concentrations (equivalent to 2, 4 and 8g/ml). |
P790018/S028
4/7/97 |
Medtronic Hall Prosthetic Heart Valve | Medtronic Heart Valves
Minneapolis, MN 55440 |
Approval for a modification to the sterilization method and packaging system. |
P810046/S168
4/21/97 |
ACS RX ELIPSE .014 Coronary Dilatation Catheter | Guidant, Corp.
Advanced Cardiovascular Systems, Inc. Santa Clara, CA 95052-8167 |
Approval for the use of a new adhesive in the manufacturing of the ACS RX ELIPSE .014 Coronary Dilatation Catheter. |
P810046/S172
4/7/97 |
ACS Tx2000 VP Coronary Dilatation Catheter | Guidant, Corp.
Advanced Cardiovascular Systems, Inc. Temecula, CA 92591-4628 |
Approval for the ACS Tx2000 VP Coronary Dilatation Catheter. This catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
P810046/S173
4/21/97 |
ACS Tx2000 Coronary Dilatation Catheter with the 15 mm, 20 mm, 30 mm, and 40 mm balloon lengths | Guidant, Corp.
Advanced Cardiovascular Systems, Inc. Santa Clara, CA 95052-8167 |
Approval for the ACS Tx2000 Coronary Dilatation Catheter with new balloon lengths (15 mm and 40 mm), additional balloon diameters for the 20 mm and 30 mm balloon lengths, and revised labeling. |
P820018/S072
4/29/97 |
Network Programmer Model 9602 | Pacesetter, Inc.
A St. Jude Medical Company Sylmar, CA 91342-3577 |
Approval for an alternate manufacturing site for the Model 9602 Programmer. The site is located at Sylmar, CA. |
P830026/S069
4/28/97 |
Rx5000 Graphics Programmer | Sulzer Intermedics, Inc.
Angleton, TX 77515 |
Approval for alternate components to be used in the manufacture of the Rx5000 Graphics Programmer. |
P830026/S070
4/17/97 |
Rx5000 Model 522-12 Version 2.01.03 Operating System | Sulzer Intermedics, Inc.
Angleton, TX 77515-2523 |
Approval for the Rx5000 Model 522-12 Version 2.01.03 Operating System. |
P830055/S054
4/30/97 |
new jersey LCS Total Knee System | Depuy, Inc.
Warsaw, IN 46581-0988 |
Approval for a change to the depth of the bone graft pockets of the textured and porous coated femoral components of the new jersey LCS Total Knee System. |
P840001/S040
4/25/97 |
Medtronic Itrel® Spinal Cord Stimulator | Medtronic Neurological
Minneapolis, MN 55440-9087 |
Approval for design changes for the Itrel® series of neurological pulse generators, including the Itrel®, Itrel® II, and Itrel® 3. |
P840008/S057
4/29/97 |
MFL5000 Lithotripter and the Dornier Lithotripter (Stationary and Transportable) | Dornier Medical Systems, Inc.
Kennesaw, GA 30144 |
Approval for non-ECG shock wave trigger modes. |
P840024/S068
4/4/97 |
Audallion Beam Forming Pre-Processor to be used with the Nucleus 22-Channel Cochlear Implant System and Device Effectiveness Claims for the Audallion as used in Conjunction with the System | Cochlear, Corp.
Englewood, CO 80112 |
Indicated for use by adults who are using the Nucleus 22 Channel Cochlear Implant System to aid them in improving speech understanding in noisy environments when the speech and the noise are not coming from the same direction. |
P850007/S018
4/16/97 |
Physio-Stim® Lite Models 202L, 303L, 404L, 313L, and 314L | Orthofix, Inc.
Richardson, TX 75081 |
Approval for modifications to the design and labeling of the Physio-Stim® Bone Growth Stimulator. The device, as modified, is to be marketed under the trade name Physio-Stim® Lite and is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. |
P850020/S009
4/17/97 |
Prosorba Column | Cypress Bioscience, Inc.
Redmond, WA 98052 |
Approval for consolidation of manufacturing operations at Cypress Bioscience, Redmond, WA. |
P850035/S022
4/22/97 |
SpF-XL IIb Implantable Spinal Fusion Stimulator | Electro-Biology, Inc.
Parsippany, NJ 07054 |
Approval for the SpF-XL IIb Implantable Spinal Fusion Stimulator which is a modification of the SpF-XL II Implantable Spinal Fusion Stimulator. The SpF-XL IIb Implantable Spinal Fusion Stimulator has a smaller generator case than the SpF-SL II Implantable Spinal Fusion Stimulator. The device, as modified, will be marketed under the trade name the SpF-XL IIb Implantable Spinal Fusion Stimulator and is indicated for use as a spinal fusion adjunct to increase the probability of fusion success in 3 or more levels. |
P860019/S113 4/9/97 |
SCIMED® TRANSPORT® Coronary Balloon Dilatation-Infusion Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a new balloon dilatation and infusion catheter. The device will be marketed under the trade name SCIMED® TRANSPORT® Coronary Balloon Dilatation-Infusion 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. The TRANSPORT® catheter is also intended to infuse fluids such as heparinized saline, and thrombolytic agents such as urokinase, into the vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atmospheres. |
P860019/S118
4/24/97 |
SCIMED® REBEL Percutaneous Transluminal Angioplasty (PTCA) Catheters | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a new single-operator exchange catheter with a self-contained contrast displacement system. The device, as modified, will be marketed under the trade name SCIMED® REBEL Percutaneous Transluminal Angioplasty (PTCA) Catheters 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. |
P870072/S003
4/17/97 |
Thoratec® Ventricular Assist Device (VAD) | Thoratec Laboratories, Corp.
Berkeley, CA 94710-2090 |
Approval for adding an alternate contract sterilizer facility, and changing the material and configuration of the storage box for the pumps and cannulae. |
P880003/S065
4/30/97 |
Valor and Valor XL PTCA Dilatation Catheters | Cordis, Corp.
Miami Lakes, FL 33102-5700 |
Approval for Valor and Valor XL PTCA Dilatation Catheters with 2.25 mm, 2.75 mm, 3.25 mm, and 3.75 mm diameter balloons in lengths of 10 mm and 15 mm. |
P880003/S066
4/30/97 |
Thor PTCA Dilatation Catheters | Cordis, Corp.
Miami Lakes, FL 33102-5700 |
Approval for Thor PTCA Dilatation Catheters with 10 mm and 40 mm long balloons. |
P880031/S011
4/9/97 |
VITRAX® (Sodium Hyaluronate) | Allergan Medical Optics
Irvine, CA 92713-9534 |
Approval for an alternate manufacturing site, alternate contract sterilization facility, and an 18 month shelf life. |
P880038/S034
4/29/97 |
Network Programmer Model 9602 | Pacesetter, Inc.
A St. Jude Medical Company Sylmar, CA 91342-3577 |
Approval for an alternate manufacturing site for the Model 9602 Programmer. The site is located at Sylmar, CA. |
P880072/S044
4/15/97 |
Model TC-65B-SUV, Posterior Chamber Intraocular Lens | Medical Developmental Research, Inc.
St. Petersburg, FL 33716 |
Approval for Model TC-65B-SUV as a Tier A modification of parent Model PA17E-OUV. |
P880087/S009
4/22/97 |
Models MT, MTU, MTA, and MTAU Anterior Chamber Intraocular Lenses (IOLs) | Alcon Laboratories, Inc.
Fort Worth, TX 76134-2099 |
Approval for labeling changes. |
P880091/S007
4/4/97 |
ELASTIMIDE® Ultraviolet-Absorbing Silicone Multipiece Posterior Chamber Intraocular Lenses (IOLS), Models AQ-1016V, AQ-2003V, AQ-2013V and AQ-2010V | Staar Surgical Company
Monrovia, CA 91016 |
Approval to revise the Directions for Use insert to recommend an additional insertion instrument, the MICROSTAAR injection system (Models MSI-TD and MSI-PD). |
P890027/S037
4/1/97 |
Nucleus 22 Channel Cochlear System for Children | Cochlear, Corp.
Englewood, CO 80112 |
Approval for an additional new sterilization site at Griffith Microscience, Willowbrook, IL. |
P900023/S021
4/16/97 |
Abiomed® BVS 5000® Bi-Ventricular Support System | Abiomed, Inc.
Danvers, MA 01923 |
Approval for an increase in the sterilizer load size. |
P900070/S018
4/29/97 |
META MV Cardiac Pulse Generator Model 1256D | Pacesetter, Inc.
A St. Jude Medical Company Sylmar, CA 91342-3577 |
Approval for an alternate manufacturing site located at Sylmar, CA. |
P900070/S019 | Network Programmer Model 9602 | Pacesetter, Inc.
A St. Jude Medical Company Sylmar, CA 91342-3577 |
Approval for an alternate manufacturing site for the Model 9602 Programmer. The site is located at Sylmar, CA. |
P910023/S023
4/17/97 |
Programmer Software Version, PRS V4.2H | Ventritex, Inc.
Sunnyvale,CA 94086-6527 |
Approval for a new Version of Programmer Software for the Ventritex® Programmer PR-1500. The device, as modified, will be marketed under the trade name PRS V4.2H and is indicated for use with Programmer PR-1500 and Cadence pulse generator Models v-100, V-110, V-112; Cadet pulse generator Models V-105, V-115 and Contour pulse generator Models V-135, V-145. |
P910031/S011
4/9/97 |
Lynx Balloon Coronary Dilatation Catheter | CardioVascular Dynamics, Inc.
Irvine, CA 92618 |
Approval for 1)change in balloon design; 2)change in catheter shaft material; 3)change in internal shaft design; 4)change in the balloon/shaft bonding method; 5) change in balloon lengths; and 6)change in the color of the catheter shaft |
P920004/S006
4/15/97 |
VasoSeal Vascular Hemostasis Device | Datascope, Corp.
Montvale, NJ 07645 |
Approval for a change to the indications for use to include use of VasoSeal® following stent implantation. The VasoSeal® Vascular Hemostasis Device is now indicated for use in reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography, balloon angioplasty or stent procedures using an 8 French or smaller procedural sheath and using a retrograde approach. The device is also indicated for use in reducing time to hemostasis in balloon angioplasty and stent patients when immediate sheath removal is desired. However, early ambulation in these patients has not been demonstrated. |
P920023/S001
4/11/97 |
UroLume Endourethral Prosthesis Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH) | American Medical Systems, Inc.
Minnetonka, MN 55343 |
Intended to relieve prostatic obstruction secondary to BPH in men at least 60 years of age, or men under 60 years of age or poor surgical candidates, and whose prostates are at least 2.5cm in length. |
P920023/S003
4/29/97 |
UroLume® Endourethral Prosthesis for Urethral Stricutres | American Medical Systems, Inc.
Pfizer Hospital Products Group Minnetonka, MN 55343 |
Approval for changes to the post-approval studies. |
P930014/S004
4/22/97 |
Acrysof® Molded Acrylic Posterior Chamber Ultraviolet-Absorbing Intraocular Lenses (IOLS) | Alcon Laboratories, Inc.
Fort Worth, TX 76134-2099 |
Labeling changes. |
P930016/S003
4/24/97 |
VISX Excimer Laser system Models "B" and "C" | VISX, Inc.
Santa Clara, CA 95051 |
Indicated for myopic astigmatic photrefractive keratectomy (PRKa) using an ablation zone with a 6.0 mm major axis. PRKa is intended for use: 1)in PRKa treatments for the reduction or elimination of mild to moderate myopia between 0 and -6.0 D spherical myopia at the spectacle plane (with a vertex distance of 12.5 mm), and concomitant reduction or elimination of refractive cylinder of not less than 0.75D and not more than 4.0D at the spectacle plane (with a vertex distance of 12.5 mm) as determined by minus cylinder refraction; 2)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 pre-operative examination; and, 3)in patients who are 21 years of age or older. |
P930031/S004
4/15/97 |
Wallstent® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis | Schneider (USA), Inc.
Minneapolis, MN 55442 |
Approval for an alternative delivery system which allows the user to partially deploy and then reconstrain the stent to facilitate placement. |
P930038/S002
4/25/97 |
Angio-Seal Hemostatic Puncture Closure Device | Quinton Instrument Company
Bothell, WA 98021-8906 |
Approval for labeling changes. |
P930038/S004
4/25/97 |
Angio-Seal Hemostatic Puncture Closure Device | Quinton Instrument Company
Bothell, WA 98021-8906 |
Modifications to the manufacturing process to eliminate the potential for damage of the suture component. |
P940002/S001
4/30/97 |
Natural-Knee® and Natural-Knee® II with CSTi | Sulzer Orthopedics, Inc.
Austin, TX 78717 |
Approval for postapproval protocol and modifications to the package inserts. |
P940007/S003
4/11/97 |
CeeOn® Model 912 Ultraviolet-Absorbing Silicone Posteror Chamber Intraocular Lens (IOL) | Pharmacia & Upjohn | Approval for Model 912 as a Tier A modification of the clinical parent lenses previously approved under this PMA. This device, as modified, will be marketed under the trade name CeeOn® and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification or extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. |
P940008/S005
4/25/97 |
Rx2000 GRAPHICS Program Module | Sulzer Intermedics, Inc.
Angleton, TX 77515 |
Approval for software modifications to the Model 531-30 Rx2000 GRAPHICS Program Module. |
P940010/S003
4/4/97 |
OPTIGUIDE Fiber Optic Diffuser DCYL Series | QLT Phototherapeutics, Inc.
Washington, D.C. 20004-1109 |
Approval for labeling changes associated with the introduction of a second distributor. |
P940019/S002
4/14/97 |
WALLSTENT Iliac Endoprosthesis | Schneider (USA), Inc.
Minneapolis, MN 55442 |
Approval for an alternate delivery system for the WALLSTENT Iliac Endoprosthesis (the UNISTEP Pluse Delivery System). |
P950019/S001
4/11/97 |
Ray Threaded Fusion Cage (TFC) with instrumentation | United States Surgical, Corp.
Norwalk, CT 06856 |
Approval for additional instruments and a change to the surgical technique manual. |
P950022/S001
4/23/97 |
RV Lead Model RV03, SVC Lead Models SV04 and SV05 with a solid suture sleeve, Stylet Models S-70-R, S-70-F, S-45-X, S-55-X and S-70-X | Ventritex, Inc.
Sunnyvale, CA 94086-6527 |
Approval for use of a laser process to remove excess silicone rubber from the defibrillation coils. |
P950039/S003
4/8/97 |
ThinPrep® 2000 System | Cytyc, Corp.
Boxborough, MA 01719 |
Approval for the use of polyethylene terephthalate (polyester) as an alternative membrane material for the TransCyt Filter for gynecological specimens and the use of the polycarbonate TransCyt Filters with the modified software on the ThinPrep® 2000 System. |
P960001/S002
4/3/97 |
DePuy 1 Bone Cement | Depuy, Inc.
Warsaw, IN 46581-0988 |
Approval for packaging Depuy 1 Bone Cement powder without the foil pouch. |
P960012/S001
4/24/97 |
REFRESH® CL Lubricating & Rewetting Drops | Allergan Optical
Irvine, CA 92623-9534 |
Approval to add rigid gas permeable contact lenses to the label indications. |
P960019/S001
4/07/97 |
LaserVision®/ VISX Excimer Laser System Model C for Phototherapeutic Keratectomy (PTK) and Photorefractive Keratectomy (PRK) | LaserVision Centers, Inc.
St. Louis, MO 63141 |
Approval for the device to be installed in the Calumet Coach Model MMT-436V semi-trailer coach, which will be manufactured by the Calumet Coach Company, Calumet City, IL 60409-1411. The device, as modified, will be marketed under the trade name MobilExcimer® for Phototherapeutic Keratectomy (PTK) and Photorefractive Keratectomy (PRK) |
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