Premarket Approval Decisions for September 2001

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.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P000029 9/24/01	Deflux® Injectable Gel	Q-Med AB Uppsala, Sweden S752-28	Approval for Deflux® Injectable Gel. The device is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
P000036 8/28/01	DERMAGRAFT®	Advanced Tissue Sciences La Jolla, CA 93037	Approval for the DERMAGRAFT®. The device is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure. DERMAGRAFT® should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
P010013 9/28/01	NovaSure; Impedance Controlled Endometrial Ablation System	Novacept, Inc. Palo Alto, CA 94303	Approval for the NovaSure Impedance Controlled Endometrial Ablation System. The device is intended to ablate the endometrial lining of the uterus of pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
P010017 9/25/01	SenoScan® Full Field Digital Mammography System	Fischer Imaging, Corp. Denver, CO 80241	Approval for the SenoScan® Full Field Digital Mammography System. The device is a dedicated mammography system intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The SenoScan® Full Field Digital Mammography System is intended to be used in the same clinical applications as traditional film-based mammography systems.
P010023 9/7/01	SOUNDTEC® Direct System	SOUNDTEC, Inc. Oklahoma City, OK 73112	Approval for the SOUNDTEC® Direct System. This device is indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P000029

9/24/01

Deflux® Injectable Gel

Q-Med AB

Uppsala, Sweden

S752-28

Approval for Deflux® Injectable Gel. The device is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.

P000036

8/28/01

DERMAGRAFT®

Advanced Tissue Sciences

La Jolla, CA

93037

Approval for the DERMAGRAFT®. The device is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure. DERMAGRAFT® should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.

P010013

9/28/01

NovaSure; Impedance Controlled Endometrial Ablation System

Novacept, Inc.

Palo Alto, CA

94303

Approval for the NovaSure Impedance Controlled Endometrial Ablation System. The device is intended to ablate the endometrial lining of the uterus of pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

P010017

9/25/01

SenoScan® Full Field Digital Mammography System

Fischer Imaging, Corp.

Denver, CO

80241

Approval for the SenoScan® Full Field Digital Mammography System. The device is a dedicated mammography system intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The SenoScan® Full Field Digital Mammography System is intended to be used in the same clinical applications as traditional film-based mammography systems.

P010023

9/7/01

SOUNDTEC® Direct System

SOUNDTEC, Inc.

Oklahoma City, OK

73112

Approval for the SOUNDTEC® Direct System. This device is indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P830037/S044 9/14/01 135-Day	Phemfilcon A soft (hydrophilic) contact lens	CIBA Vision Corporation Duluth, GA 30097	Approval for a material change to incorporate the use of a different adhesion promoter to be used in the pigment application process.
P830045/S077 9/5/01 Real-Time	Model 3307 Version 2.4a Programmer Software	St. Jude Medical Sylmar, CA 91342	Approval for the Model 3307 Version 2.4a Programmer Software.
P860019/S176 9/7/01 180-Day	Scimed and Schneider PTCA Catheters	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the alternate facilities for packaging and labeling located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands.
P880003/S082 9/27/01 180-Day	RAPTORAIL™ PTCA Dilatation Catheter	Cordis Corp. Miami, FL 33102	Approval for a new catheter model. The device, as modified, will be marketed under the trade name RAPTORAIL™ PTCA 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.
P880027/S061 9/7/01 180-Day	Scimed and Schneider PTCA Catheters	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the alternate facilities for packaging and labeling located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands.
P880086/S084 9/5/01 Real-Time	Model 3307 Version 2.4a Programmer Software	St. Jude Medical Sylmar, CA 91342	Approval for the Model 3307 Version 2.4a Programmer Software.
P890057/S014 9/24/01 Panel	Model 3100B High-Frequency Oscillatory Ventilator (HFOV)	SensorMedics Corp. Yorba Linda, CA 92687	Approval for the Model 3100B HFOV. The device is indicated for use in the ventilatory support and treatment of selected patients 35 kilograms and greater with acute respiratory failure.
P900009/S013 9/4/01 180-Day	Exogen 2000 Sonic Accelerated Fracture Healing System (SAFHS®)	Smith & Nephew, Inc. Memphis, TN 38116	Approval for the low intensity ultrasound Fracture treatment system, Sonic Accelerated Fracture Healing System (SAFHS®). The device , as modified, will be marketed under the trade name Exogen 2000 Sonic Accelerated Fracture Healing System (SAFHS®) and is indicated for the non-invasive treatment of established nonunions* excluding skull and vertebra. In addition, the Exogen 2000+™ or Sonic Accelerated Fracture Healing System (SAFHS®) is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade 1 open tibial diaphysis in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
P900043/S027 9/21/01 180-Day	BX VELOCITY Stent on RaptorRail™ Stent Delivery System (RX) with 3.0 mm � 5.0 mm diameters and 8 mm � 33 mm lengths	Cordis Corp. Warren, NJ 07059	Approval for the elective indication as specified: For treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤ 30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 to 5.0 mm.
P900043/S028 9/21/01 180-Day	BX VELOCITY™ with HEPACOAT™ on Raptor™ Stent System	Cordis Corp. Warren, NJ 07059	Approval for a new indication (elective stenting of de novo and restenotic coronary arteries) and additional stent diameters (4.5 and 5.0 mm) for the BX VELOCITY™ with HEPACOAT™ on Raptor™ Stent System. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤ 30 mm in length in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (≤ 30 mm in length) with reference diameters in the range of 2.25 mm in 4.00 mm. The 2.25 mm, 2.50 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.
P900056/S064 9/7/01 180-Day	Rotablator® Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052	Approval for the alternate manufacturing facilities located at Plexus Corporation, Bothell, Washington for the manufacture of the Rotablator® Console and Dynaglide™ Foot Pedal and Boston Scientific Scimed IVUS Technology Center, Fremont, California for inspection functions.
P900061/S046 9/5/01 Real-Time	Medtronic® Model 5719 Active Can® Emulator (ACE) and Model 5460 ACE Header	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic® Model 5719 Active Can® Emulator (ACE) and Model 5460 ACE Header. The device is used to emulate an implantable device during defibrillation efficacy testing.
P910023/S054 9/5/01 Real-Time	Model 3307 Version 2.4a Programmer Software	St. Jude Medical Sylmar, CA 91342	Approval for the Model 3307 Version 2.4a Programmer Software.
P920004/S015 9/20/01 180-Day	VasoSeal® ES and VasoSeal® VHD	Datascope Corp. Mahwah, NJ 07430	Approval to modify language in the Instructions for Use (IFU) for the VasoSeal® EA and VasoSeal® VHD devices to add clinical study data to the labeling for both devices in support of a new claim for reduced time-to-discharge for diagnostic angiography patients and to expand the indications for use for the VasoSeal® VHD device from balloon angioplasty or stent procedures to the general category of interventional procedures. The devices, as modified, will be marketed under the trade names VasoSeal® ES and VasoSeal® VHD and the VasSeal® VHD is indicated for use in sealing the femoral arterial puncture site in patients who have undergone diagnostic and interventional catheterization procedures using an 8 French or smaller procedural sheath and retrograde approach. The VasoSeal® VHD reduces time to hemostasis, and ambulation in patients who have undergone diagnostic or interventional catheterization procedures. In addition, the VasoSeal® VHD reduces time to discharge in diagnostic patients. The VasoSeal® VHD also reduces time to hemostasis in interventional patients, when immediate sheath removal is desired. However, early ambulation in these patients has not been demonstrated.
P950014/S021 9/19/01 180-Day	Prostatron	Urologix Minneapolis, MN 55447	Approval for a new manufacturing site located at Venusa de Mexico S.A. de C.V, Chihuahua, Mexico, in which the Prostatron Disposable Treatment Applicator will be assembled. In addition, approval for a manufacturing facility located at Venusa Ltd., El Paso, Texas, for the receipt, inspection, storage, and release of components and the quarantine of finished sterilized devices. Also, the applicator will be sterilized at Griffith MicroScience, Santa Teresa, New Mexico.
P950022/S013 9/26/01 180-Day	TVL® Lead System	St. Jude Medical, Inc. Sunnyvale, CA 94086	Approval for the alternate manufacturing facility located at St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California.
P950035/S010 9/13/01 Special	NeuroControl Freehand® System	NeuroControl Corp. Valley View, OH 44125	Approval for revisions to the labeling that specify the maximum depth below the surface of the skin at which the Implantable Receiver-Stimulator (IRS) should not exceed when implanted and clarifying the instructions for connecting the External Controller to the Clinical Programming Station.
P950037/S021 9/10/01 180-Day	EDP 30 External Dual Chamber Pacemaker	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the External Dual-Chamber Pacemaker Model EDP 30. The device, as modified, will be marketed under the trade name EDP 30 and is indicated for: 1) Temporary treatment of arrhythmias and heart block; 2) Pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; 3) Prophylactic pacing for prevention of arrhythmias; and 4) Emergency pacing.
P960025/S007 9/17/01 180-Day	Lumbar I/F Cage System	DePuy AcroMed Raynham, MA 02767	Approval for an additional manufacturing facility located at DePuy AcroMed, Raynham, Massachusetts.
P970003/S035 9/4/01 Special	NeuroCybernetic Prosthesis (NCP®) System	Cyberonics, Inc. Houston, TX 77058	Approval for a change to the labeling to add a contraindication regarding the use of diathermy on patients implanted with the NeuroCybernetic Prosthesis (NCP®) System.
P970004/S016 9/7/01 180-Day	InterStim Model 3095 Lead Extension	Medtronic, Inc. Minneapolis, MN 55421	Approval for an alternate manufacturing facility located at Medtronic Neurological Puerto Rico Operations (MNPRO), Villalba, Puerto Rico.
P970053/S006 9/4/01 180-Day	Nidek EC-5000 Excimer Laser System	Nidek Technologies, Inc. Pasadena, CA 91105	Approval to modify the approved claim for the EC-5000 Excimer Laser System to allow for treatments using an optical zone size of 5.5 mm to 6.5 mm, in addition to the approved optical zone size of 5.5 mm, for LASIK treatment of myopia and myopia with astigmatism. The device, as modified, will continue to be marketed under the trade name Nidek EC-5000 Excimer Laser System and remains indicated for the reduction or elimination of �1.00 D to �14.00 D myopia spherical equivalent with or without <=-4 D astigmatism.
P980001/S037 9/20/01 180-Day	NIR® Premounted Stent Delivery Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the alternate manufacturing facilities for packaging and labeling located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands.
P980008/S005 9/28/01 Panel	LaserSight LaserScan LSX Excimer Laser System for Laser-Assisted In Situ Keratomileusis (LASIK)	LaserSight Technologies, Inc. Winter Park, FL 32792	Approval for the LaserSight LaserScan LSX Excimer Laser System for Laser-Assisted In Situ Keratomileusis (LASIK). The device is indicated for LASIK: 1) for the reduction or elimination of myopia ranging from �0.5 to less than �6.0 diopters (D) spherical equivalent, with astigmatism less than or equal to 4.5 D, as measured at the spectacle plane; 2) in patients with documentation of a stable manifest refraction defined as ≤ 0.50 D, or ≤ 10% of preoperative spherical equivalent refraction (SER) shift over one year prior to surgery; and, 3) in patients who are 18 years of age or older.
P980016/S020 9/5/01 180-Day	Medtronic® GEM DR Model 7271 ICD	Medtronic, Inc. Minneapolis, MN 55432	Approval for the alternate manufacturing and sterilization facility located at Medtronic Europe S.A., Tolochenaz, Switzerland and an alternate packaging facility located at Medtronic BV Kerkrade, the Netherlands.
P990017/S011 9/20/01 180-Day	ANCURE® Endovascular Graft Tube and Bifurcated Systems	Guidant Corp. Menlo Park, CA 94025	Approval for modifications to the five year follow-up protocol: a) changing the follow-up schedule; b) removing the ultrasound and ankle brachial indices (ABI) assessments; c) replacing the annual physical exam for control patients with an annual telephone survey and computed tomography (CT) and physical exam at the five year mark; d) allowing an optional telephone survey for patients unable or unwilling to come to the investigational site; and e) excluding patients who have been converted from further study follow-up.
P990025/S002 9/26/01 180-Day	NaviStar Deflectable Tip Diagnostic/ Ablation Catheter	Biosense Webster Diamond Bar, CA 91765	Approval for expanding the Indications for Use. The device, as modified, will be marketed under the trade name NaviStar Deflectable Tip Diagnostic/Ablation Catheter and is indicated a follows: The Biosense Webster NAVI-STAR Diagnostic/Ablation Catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping, and for use with a compatible RF generator in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used with the CARTO EP Navigation System, the NAVI-STAR Diagnostic/Ablation catheter provides location information.
P990027/S003 9/25/01 180-Day	TECHNOLAS® 217A Excimer Laser System for Laser In-Situ Keratomileusis (LASIK) for the reduction or elimination of �1.00 D to �12.00 D spherical myopia with or without <-3.50 D astigmatism	Bausch & Lomb Surgical Claremont, CA 91711	Approval to add an active eyetracker as an accessory to the laser system.
P990048/S001 9/27/01 180-Day	VISULAS 690s and VISULINK PDT/U Adapter	Carl Zeiss Inc. Thornwood, NY 10594	Approval for a revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis, or pathologic myopia."
P990049/S001 9/27/01 180-Day	Coherent Opal Photoactivator	Lumenis, Inc. Santa Clara, CA 95051	Approval for a revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis."
P990074/S009 9/21/01 Special	McGhan RTV Saline-Filled Breast Implants � Styles 68, 163, 168, 363 and 468	McGhan Medical Corp. Santa Barbara, CA 93111	Approval to add mechanical testing of sample shells produced as part of the incoming inspection process for the RTV silicone dispersion. This testing serves as an additional criterion for the acceptance of the raw material used to make all styles of the saline-filled breast implants.
P990075/S004 9/5/01 180-Day	Saline-Filled Mammary Prosthesis � Styles 5000 and 5000PT and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis � Styles 6000 and 6000PT	Mentor Corp. Santa Barbara, CA 93111	Approval for 1) an increase in the thickness of the shell radius/base for Style 5000PT and 2) a decrease in thickness of the textured layer from 0.02" to 0.01" for Styles 5000, 5000PT, 6000, and 6000 PT. The second change effectively withdraws the approved change in supplement 2.
P990085/S001 9/19/01 Real-Time	Lenefilcon A Hydrophilic Contact Lenses	Vistakon, Johnson & Johnson Vision Care, Inc. Jacksonville, FL 01057	Approval for an alternate package integrity test method to support shelf-life and assign expiration dates in lieu of sterility testing.
P000009/S002 9/4/01 Real-Time	Tachos DR Implantable Cardioverter Defibrillator (ICD) System	Biotronik, Inc. Lake Oswego, OR 97053	Approval for changes to the embedded and programmer software for the Tachos DR. The new version number for the software cartridge for Tachos DR/Phylax AV/TMS 1000 applications is I-HDR.0.U/4 (Model 338 373). The device, as modified will be marketed under the trade name Tachos DR Implantable Cardioverter Defibrillator (ICD) System and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.
P000022/S007 9/26/01 180-Day	BeStent™ 2 Coronary Stent System	Medtronic AVE, Inc. Santa Rosa, CA 95403	Approval for amending the test of the BeStent 2 Post-Approval Study Protocol to reflect administrative updates.
P000032S001 9/7/01 Special	HerOption™ Uterine Cryoblation Therapy™ System	CryoGen, Inc. San Diego, CA 92121	Approval for revisions to the HerOption™ Uterine Cryoblation Therapy™ System labeling.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P830037/S044

9/14/01

135-Day

Phemfilcon A soft (hydrophilic) contact lens

CIBA Vision Corporation

Duluth, GA

30097

Approval for a material change to incorporate the use of a different adhesion promoter to be used in the pigment application process.

P830045/S077

9/5/01

Real-Time

Model 3307 Version 2.4a Programmer Software

St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3307 Version 2.4a Programmer Software.

P860019/S176

9/7/01

180-Day

Scimed and Schneider PTCA Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for the alternate facilities for packaging and labeling located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands.

P880003/S082

9/27/01

180-Day

RAPTORAIL™ PTCA Dilatation Catheter

Cordis Corp.

Miami, FL

33102

Approval for a new catheter model. The device, as modified, will be marketed under the trade name RAPTORAIL™ PTCA 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.

P880027/S061

9/7/01

180-Day

Scimed and Schneider PTCA Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

P880086/S084

9/5/01

Real-Time

Model 3307 Version 2.4a Programmer Software

St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3307 Version 2.4a Programmer Software.

P890057/S014

9/24/01

Panel

Model 3100B High-Frequency Oscillatory Ventilator (HFOV)

SensorMedics Corp.

Yorba Linda, CA

92687

Approval for the Model 3100B HFOV. The device is indicated for use in the ventilatory support and treatment of selected patients 35 kilograms and greater with acute respiratory failure.

P900009/S013

9/4/01

180-Day

Exogen 2000 Sonic Accelerated Fracture Healing System (SAFHS®)

Smith & Nephew, Inc.

Memphis, TN

38116

Approval for the low intensity ultrasound Fracture treatment system, Sonic Accelerated Fracture Healing System (SAFHS®). The device , as modified, will be marketed under the trade name Exogen 2000 Sonic Accelerated Fracture Healing System (SAFHS®) and is indicated for the non-invasive treatment of established nonunions* excluding skull and vertebra. In addition, the Exogen 2000+™ or Sonic Accelerated Fracture Healing System (SAFHS®) is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade 1 open tibial diaphysis in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.

*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

P900043/S027

9/21/01

180-Day

BX VELOCITY Stent on RaptorRail™ Stent Delivery System (RX) with 3.0 mm � 5.0 mm diameters and 8 mm � 33 mm lengths

Cordis Corp.

Warren, NJ

07059

Approval for the elective indication as specified: For treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤ 30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 to 5.0 mm.

P900043/S028

9/21/01

180-Day

BX VELOCITY™ with HEPACOAT™ on Raptor™ Stent System

Cordis Corp.

Warren, NJ

07059

Approval for a new indication (elective stenting of de novo and restenotic coronary arteries) and additional stent diameters (4.5 and 5.0 mm) for the BX VELOCITY™ with HEPACOAT™ on Raptor™ Stent System. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤ 30 mm in length in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (≤ 30 mm in length) with reference diameters in the range of 2.25 mm in 4.00 mm. The 2.25 mm, 2.50 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.

P900056/S064

9/7/01

180-Day

Rotablator® Rotational Angioplasty System

Boston Scientific Corporation

Redmond, WA

98052

Approval for the alternate manufacturing facilities located at Plexus Corporation, Bothell, Washington for the manufacture of the Rotablator® Console and Dynaglide™ Foot Pedal and Boston Scientific Scimed IVUS Technology Center, Fremont, California for inspection functions.

P900061/S046

9/5/01

Real-Time

Medtronic® Model 5719 Active Can® Emulator (ACE) and Model 5460 ACE Header

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® Model 5719 Active Can® Emulator (ACE) and Model 5460 ACE Header. The device is used to emulate an implantable device during defibrillation efficacy testing.

P910023/S054

9/5/01

Real-Time

Model 3307 Version 2.4a Programmer Software

St. Jude Medical

Sylmar, CA

91342

Approval for the Model 3307 Version 2.4a Programmer Software.

P920004/S015

9/20/01

180-Day

VasoSeal® ES and VasoSeal® VHD

Datascope Corp.

Mahwah, NJ

07430

Approval to modify language in the Instructions for Use (IFU) for the VasoSeal® EA and VasoSeal® VHD devices to add clinical study data to the labeling for both devices in support of a new claim for reduced time-to-discharge for diagnostic angiography patients and to expand the indications for use for the VasoSeal® VHD device from balloon angioplasty or stent procedures to the general category of interventional procedures. The devices, as modified, will be marketed under the trade names VasoSeal® ES and VasoSeal® VHD and the VasSeal® VHD is indicated for use in sealing the femoral arterial puncture site in patients who have undergone diagnostic and interventional catheterization procedures using an 8 French or smaller procedural sheath and retrograde approach. The VasoSeal® VHD reduces time to hemostasis, and ambulation in patients who have undergone diagnostic or interventional catheterization procedures. In addition, the VasoSeal® VHD reduces time to discharge in diagnostic patients. The VasoSeal® VHD also reduces time to hemostasis in interventional patients, when immediate sheath removal is desired. However, early ambulation in these patients has not been demonstrated.

P950014/S021

9/19/01

180-Day

Prostatron

Urologix

Minneapolis, MN

55447

Approval for a new manufacturing site located at Venusa de Mexico S.A. de C.V, Chihuahua, Mexico, in which the Prostatron Disposable Treatment Applicator will be assembled. In addition, approval for a manufacturing facility located at Venusa Ltd., El Paso, Texas, for the receipt, inspection, storage, and release of components and the quarantine of finished sterilized devices. Also, the applicator will be sterilized at Griffith MicroScience, Santa Teresa, New Mexico.

P950022/S013

9/26/01

180-Day

TVL® Lead System

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the alternate manufacturing facility located at St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California.

P950035/S010

9/13/01

Special

NeuroControl Freehand® System

NeuroControl Corp.

Valley View, OH

44125

Approval for revisions to the labeling that specify the maximum depth below the surface of the skin at which the Implantable Receiver-Stimulator (IRS) should not exceed when implanted and clarifying the instructions for connecting the External Controller to the Clinical Programming Station.

P950037/S021

9/10/01

180-Day

EDP 30 External Dual Chamber Pacemaker

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the External Dual-Chamber Pacemaker Model EDP 30. The device, as modified, will be marketed under the trade name EDP 30 and is indicated for: 1) Temporary treatment of arrhythmias and heart block; 2) Pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; 3) Prophylactic pacing for prevention of arrhythmias; and 4) Emergency pacing.

P960025/S007

9/17/01

180-Day

Lumbar I/F Cage System

DePuy AcroMed

Raynham, MA

02767

Approval for an additional manufacturing facility located at DePuy AcroMed, Raynham, Massachusetts.

P970003/S035

9/4/01

Special

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Houston, TX

77058

Approval for a change to the labeling to add a contraindication regarding the use of diathermy on patients implanted with the NeuroCybernetic Prosthesis (NCP®) System.

P970004/S016

9/7/01

180-Day

InterStim Model 3095 Lead Extension

Medtronic, Inc.

Minneapolis, MN

55421

Approval for an alternate manufacturing facility located at Medtronic Neurological Puerto Rico Operations (MNPRO), Villalba, Puerto Rico.

P970053/S006

9/4/01

180-Day

Nidek EC-5000 Excimer Laser System

Nidek Technologies, Inc.

Pasadena, CA

91105

Approval to modify the approved claim for the EC-5000 Excimer Laser System to allow for treatments using an optical zone size of 5.5 mm to 6.5 mm, in addition to the approved optical zone size of 5.5 mm, for LASIK treatment of myopia and myopia with astigmatism. The device, as modified, will continue to be marketed under the trade name Nidek EC-5000 Excimer Laser System and remains indicated for the reduction or elimination of �1.00 D to �14.00 D myopia spherical equivalent with or without <=-4 D astigmatism.

P980001/S037

9/20/01

180-Day

NIR® Premounted Stent Delivery Systems

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for the alternate manufacturing facilities for packaging and labeling located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands.

P980008/S005

9/28/01

Panel

LaserSight LaserScan LSX Excimer Laser System for Laser-Assisted In Situ Keratomileusis (LASIK)

LaserSight Technologies, Inc.

Winter Park, FL

32792

Approval for the LaserSight LaserScan LSX Excimer Laser System for Laser-Assisted In Situ Keratomileusis (LASIK). The device is indicated for LASIK: 1) for the reduction or elimination of myopia ranging from �0.5 to less than �6.0 diopters (D) spherical equivalent, with astigmatism less than or equal to 4.5 D, as measured at the spectacle plane; 2) in patients with documentation of a stable manifest refraction defined as ≤ 0.50 D, or ≤ 10% of preoperative spherical equivalent refraction (SER) shift over one year prior to surgery; and, 3) in patients who are 18 years of age or older.

P980016/S020

9/5/01

180-Day

Medtronic® GEM DR Model 7271 ICD

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the alternate manufacturing and sterilization facility located at Medtronic Europe S.A., Tolochenaz, Switzerland and an alternate packaging facility located at Medtronic BV Kerkrade, the Netherlands.

P990017/S011

9/20/01

180-Day

ANCURE® Endovascular Graft Tube and Bifurcated Systems

Guidant Corp.

Menlo Park, CA

94025

Approval for modifications to the five year follow-up protocol: a) changing the follow-up schedule; b) removing the ultrasound and ankle brachial indices (ABI) assessments; c) replacing the annual physical exam for control patients with an annual telephone survey and computed tomography (CT) and physical exam at the five year mark; d) allowing an optional telephone survey for patients unable or unwilling to come to the investigational site; and e) excluding patients who have been converted from further study follow-up.

P990025/S002

9/26/01

180-Day

NaviStar Deflectable Tip Diagnostic/ Ablation Catheter

Biosense Webster

Diamond Bar, CA

91765

Approval for expanding the Indications for Use. The device, as modified, will be marketed under the trade name NaviStar Deflectable Tip Diagnostic/Ablation Catheter and is indicated a follows: The Biosense Webster NAVI-STAR Diagnostic/Ablation Catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping, and for use with a compatible RF generator in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used with the CARTO EP Navigation System, the NAVI-STAR Diagnostic/Ablation catheter provides location information.

P990027/S003

9/25/01

180-Day

TECHNOLAS® 217A Excimer Laser System for Laser In-Situ Keratomileusis (LASIK) for the reduction or elimination of �1.00 D to �12.00 D spherical myopia with or without <-3.50 D astigmatism

Bausch & Lomb Surgical

Claremont, CA

91711

Approval to add an active eyetracker as an accessory to the laser system.

P990048/S001

9/27/01

180-Day

VISULAS 690s and VISULINK PDT/U Adapter

Carl Zeiss Inc.

Thornwood, NY

10594

Approval for a revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis, or pathologic myopia."

P990049/S001

9/27/01

180-Day

Coherent Opal Photoactivator

Lumenis, Inc.

Santa Clara, CA

95051

Approval for a revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis."

P990074/S009

9/21/01

Special

McGhan RTV Saline-Filled Breast Implants � Styles 68, 163, 168, 363 and 468

McGhan Medical Corp.

Santa Barbara, CA

93111

Approval to add mechanical testing of sample shells produced as part of the incoming inspection process for the RTV silicone dispersion. This testing serves as an additional criterion for the acceptance of the raw material used to make all styles of the saline-filled breast implants.

P990075/S004

9/5/01

180-Day

Saline-Filled Mammary Prosthesis � Styles 5000 and 5000PT and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis � Styles 6000 and 6000PT

Mentor Corp.

Santa Barbara, CA

93111

Approval for 1) an increase in the thickness of the shell radius/base for Style 5000PT and 2) a decrease in thickness of the textured layer from 0.02" to 0.01" for Styles 5000, 5000PT, 6000, and 6000 PT. The second change effectively withdraws the approved change in supplement 2.

P990085/S001

9/19/01

Real-Time

Lenefilcon A Hydrophilic Contact Lenses

Vistakon, Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

01057

Approval for an alternate package integrity test method to support shelf-life and assign expiration dates in lieu of sterility testing.

P000009/S002

9/4/01

Real-Time

Tachos DR Implantable Cardioverter Defibrillator (ICD) System

Biotronik, Inc.

Lake Oswego, OR

97053

Approval for changes to the embedded and programmer software for the Tachos DR. The new version number for the software cartridge for Tachos DR/Phylax AV/TMS 1000 applications is I-HDR.0.U/4 (Model 338 373). The device, as modified will be marketed under the trade name Tachos DR Implantable Cardioverter Defibrillator (ICD) System and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

P000022/S007

9/26/01

180-Day

BeStent™ 2 Coronary Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for amending the test of the BeStent 2 Post-Approval Study Protocol to reflect administrative updates.

P000032S001

9/7/01

Special

HerOption™ Uterine Cryoblation Therapy™ System

CryoGen, Inc.

San Diego, CA

92121

Approval for revisions to the HerOption™ Uterine Cryoblation Therapy™ System labeling.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P950034/S020 9/28/01	Seprafilm® Bioresorbable Membrane	Genzyme Corporation Cambridge, MA 02139	Change involving converting the Seprafilm manufacturing area from a dedicated area to a shared area where Sterile Hyaluronic Acid (HA) will be produced. There will be no impact on the manufacturing processes with the proper cleaning of the three vessels. The cleaning process has been validated.
P980001/S038 9/26/01	NIR® and NIROYAL® Stent Delivery Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Alternative manufacturing process to produce balloons for the NIR® and NIROYAL® Stent Delivery Systems. The alternative process affects only the method of stretching the balloon tubing prior to molding the balloon.
P990026/S006 9/4/01	GlucoWatch® Automatic Glucose Biographer	Cygnus, Inc. Redwood City, CA 94063	Change in supplier of glucose oxidase for the AutoSensor to Toyobo Research Center Co. Ltd.
P990066/S005 9/12/01	Senographe 2000D Full Field Digital Mammography System	G.E. Medical Systems Milwaukee, WI 53188	Manufacturing process change, adding an additional test to one of the incoming inspections tests for the detector. There will be no labeling changes or design changes to the specifications of the finished device.
P000018/S017 9/26/01	Novoste™ Beta-Cath™ System	Novoste Corp. Norcross, GA 30093	Alternate method of manufacture for the drying operation of the Beta-Cath™ Delivery Catheter.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P950034/S020

9/28/01

Seprafilm® Bioresorbable Membrane

Genzyme Corporation

Cambridge, MA

02139

Change involving converting the Seprafilm manufacturing area from a dedicated area to a shared area where Sterile Hyaluronic Acid (HA) will be produced. There will be no impact on the manufacturing processes with the proper cleaning of the three vessels. The cleaning process has been validated.

P980001/S038

9/26/01

NIR® and NIROYAL® Stent Delivery Systems

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Alternative manufacturing process to produce balloons for the NIR® and NIROYAL® Stent Delivery Systems. The alternative process affects only the method of stretching the balloon tubing prior to molding the balloon.

P990026/S006

9/4/01

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Change in supplier of glucose oxidase for the AutoSensor to Toyobo Research Center Co. Ltd.

P990066/S005

9/12/01

Senographe 2000D Full Field Digital Mammography System

G.E. Medical Systems

Milwaukee, WI

53188

Manufacturing process change, adding an additional test to one of the incoming inspections tests for the detector. There will be no labeling changes or design changes to the specifications of the finished device.

P000018/S017

9/26/01

Novoste™ Beta-Cath™ System

Novoste Corp.

Norcross, GA

30093

Alternate method of manufacture for the drying operation of the Beta-Cath™ Delivery Catheter.

Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 36

Summary of PMA Originals Under Review
Total Under Review: 80
Total Active: 45
Total On Hold: 35
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review: 246
Total Active: 152
Total On Hold: 94
Number Greater Than 180 Days: 6

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 36
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 119.3
FDA Time: 84.5 Days MFR Time: 34.8 Days

Updated 03/28/2002

horizonal rule

Center for Devices and Radiological Health / CDRH

PMA Final Decisions Rendered for September 2001

PMA Original Approvals

PMA Supplemental Approvals

30-Day Notices (135 Day Supplement was not required)