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

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)

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)

Updated June 30, 1998

horizonal rule

Center for Devices and Radiological Health / CDRH

PMA Final Decisions Rendered for April 1997

PMA Original Approvals

PMA Supplemental Approvals