Premarket Approval Decisions for June 1999

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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PMA Final Decisions Rendered for June 1999

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 1999. This list is generated on a monthly basis.

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

D970003

6/3/99

Guidant PULSAR® Models 470, 970, 972, 1172, 1272 Pulse Generators; Guidant PULSAR®

PULSAR Max® Models 1170, 1171, 1270 Pulse Generators; Guidant CONSULT® (Model 2890) Software

Guidant Corporation

Cardiac Pacemakers (CPI)

St. Paul, MN

55112-5798

The Guidant PULSAR®PULSAR Max® series pacemakers are indicated for the following: 1) Symptomatic paroxysmal or permanent second or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders e.g., sinus bradycardia, sinus arrest, sinoatrial [SA] block); 4) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and 5) Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. The PULSAR® PULSAR Max® series pacemakers’ dual chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: 1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm; and 3) Low cardiac output or congestive heart failure secondary to bradycardia.

PMA ORIGINAL APPROVALS

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P970018

6/17/99

AutoCyte Prep™

AutoCyte, Inc.

Burlington, NC

27216-1029

This device is indicated as a liquid-based, thin-layer cell preparation process. The system produces slides that are intended as replacements for conventional gynecologic Pap smears. AutoCyte PREP slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.

P980022

6/15/99

MiniMed Continuous Monitoring System

MiniMed, Inc.

Sylmar, CA

91342

The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace blood glucose information obtained using standard home glucose monitoring devices. The information collected by the device may be downloaded and displayed on a computer and review by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments, which may minimize these excursions.

PMA SUPPLEMENTAL APPROVALS
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N16374/S036 6/24/99	PRONOVA™ Nonabsorbable Suture, USP (clear and pigmented)	Ethicon, Inc. Somerville, NJ 08876-0151	Approval for the PRONOVA™ Non-absorbable Suture manufactured from poly (vinylidene fluoride) and poly (vinylidene fluoride-co-hexafluoropropylene). The device, as modified, will be marketed under the trade name PRONOVA™ and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
N50510/S082 6/16/99	VITEK® 2 System	BioMerieux Vitek, Inc. Hazelwood, MI 63042	Approval for major modifications to the design of the device in order to automate manual operations and enhance its performance. The device as modified will be marketed under the trade name VITEK® 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of aerobic gram negative bacilli when tested on a Gram Negative Susceptibility Test Card.
N50510/S084 6/28/99	VITEK® 2 System	BioMerieux Vitek, Inc. Hazelwood, MI 63042-2395	Approval for the addition of four antibiotics to the Gram Positive Susceptibility Card. The device as modified will be marketed under the trade name VITEK® 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of aerobic gram positive bacteria when tested on a Gram Positive Susceptibility Test Card with specific antimicrobial agents and concentrations.
N50510/S086 6/24/99	VITEK® 2 System	BioMerieux Vitek, Inc. Hazelwood, MI 63042-2395	Approval for software revisions for major modifications to the design of the device in order to automate manual operations and enhance performance. The device as modified will be marketed under the trade name VITEK® 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of bacteria when tested on a Gram Negative Susceptibility Test Card or a Gram Positive Susceptibility Test Card containing antimicrobial agents at selected concentrations.
P810046/S198 6/4/99	ACS OTW Photon™ Coronary Dilatation Catheter	Guidant Corporation Santa Clara, Ca 95052	The device is indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.
P830061/S030* 6/16/99	Medtronic® CapSure SP Novus Model 4092 Pacing Lead and Vitatron Excellence PS+ Model IMK49B Pacing Lead	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a tine design change for the Model 4092 and IMK49B leads.
P850048/S013 6/16/99	Tandem®-R Prostate Specific Antigen (PSA) Immunoradiometric Assay and Tandem®-R Free Prostate Specific Antigen (Free PSA) Immunoradiometric Assay	Hybritech, Inc. San Diego, CA 92196	Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318.
P850048/S014 6/16/99	Tandem®-MP Prostate Specifice Antigen (PSA) Immunoenzymetric Assay	Hybritech, Inc. San Diego, CA 92196	Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Dr., Chaska, MN 55318.
P850089/S041 6/11/99	CapSure® Z Novus Model 5554 and CapSure® SP Novus Model 5592 Transvenous Tined Pacing Leads	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for labeling changes to the Technical Specification manuals for the CapSure® Z Novus Model 5554 and CapSure® SP Novus Model 5592 pacing leads.
P860004/S037 6/28/99	Medtronic® SynchroMed® Infusion System	Medtronic Neurological Minneapolis, MN 55421-1200	Approval for a labeling change to include the use of the SynchroMed Infusion System in a magnetic resonance imaging (MRI) environment.
P870015/S033* 6/21/99	STS-T Lithotripter	Mestone International, Inc. Aliso Viejo, CA 92656-4114	Approval for use of an alternate ECG monitor, minor software upgrades to version 1999.2, and associated changes to the device labeling.
P870049/S029 6/24/99	MicroScan® Rapid Fluorogenic Panels	Dade MicroScan, Inc. West Sacramento, CA 95691	Approval for the addition of a limitation to not report results for the testing of Escherichia coli and Klebsiella spp. with the antibiotic ticarcillin/K clavulanate in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.
P880086/S061* 6/17/99	Affinity DR Model 5331M/S, Affinity SR Model 5131M/S; Affinity DC Models 5230R, 5230L, 5231M/S; Entity DR Models 5326R, 5326L; and Entity DC Model 5226R Pulse Generators	St. Jude Medical, Cardiac Rhythm Management Division Sylmar, CA 91342	Approval to distribute various pulse generators.
P900056/S027 6/16/99	Rotablator Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052-3376	Approval for a labeling change for the Rotablator System.
P900060/S019 6/1/99	CPHV™ OptiForm™ Valve, Aortic Model F500 and Mitral Model F700	Sulzer Carbomedics, Inc. Austin, TX 78752-1793	Approval for a sewing cuff modification of the CarboMedics® Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name CPHV™ OptiForm™ Valve and will be available in the following model numbers and sizes: Aortic Model F500 (sizes 19, 21, 23, 25, 27, 29, and 31 mm), and Mitral Model F700 (sizes 21, 23, 25, 27, 29, 31, and 33 mm). The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.
P900061/S038* 6/16/99	Model 7227Cx GEM™ Implantable Cardioverter Defibrillator	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM™ and the Model 7273 GEM™ II DR implantable cardioverter defibrillators to correct the premature low battery problem.
P910073/S026 6/15/99	ENDOTAK® ENDURANCE EZ™ Steroid Eluting Extendable/Retractable Helix Endocardial Defibrillation Lead Models 0154, 0155, 0156 and the Accessory stylets	Guidant Cardiac Rhythm Management St. Paul, MN 55112-5798	The device is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for AICS automatic implantable cardioverter defibrillator systems.
P940031/S019 6/29/99	Meridian™, Discovery™, and Pulsar™ Pulse Generators	Guidant Corporation St. Paul, MN 55112-5798	Approval for an alternate manufacturing facility located at Guidant Ireland, Cashel Road, Clonmel Tipperary, Ireland and an alternate sterilization sited located at Isotron Ireland Ltd., Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland.
P950021/S001 6/25/99	Bayer Immuno 1™ PSA Assay	Bayer Corporation Tarrytown, NY 10591-5097	Approval for the Bayer Immuno 1™ PSA assay. This device is indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
P950032/S011* 6/24/99	Apligraf	Organogenesis, Inc. Canton, MA 02021	Approval to use a new keratinocyte cell strain (i.e., HEP 608) in the manufacture of Apligraf.
P950037/S009* 6/7/99	Actros+ Family of Pulse Generators with B-H00.0.U Software	Biotronik, Inc. Lake Oswego, OR 97035-5369	Approval for the B-H00.O.U Software module for use with the Biotronik PMS1000 series programmers, and the Actros DR+-B with dual 6mm header ports.
P960016/S001* 6/18/99	Livewire TC™ Cardiac Ablation System, Livewire TC™ EP Catheters, XLS™ Models: 402153, 402154, 402155, 402156	Daig Corporation Minnetonka, MN 55345-2126	Approval for four curve versions of the TC™ catheter line with increased lateral stability, known as the XLS™ series.
P960028/S004 6/8/99	AMO® ARRAY® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL)	Allergan, Inc. Irvine, CA 92612-9534	Approval to expand the diopter range of the ARRAY® IOL from 16-24D to 6-30D in half diopter increments.
P960043/S015 6/11/99	Techstar® XL and Prostar® XL Percutaneous Vascular Surgical (PVS) Systems	Perclose, Inc. Menlo Park, CA 94025	Approval for a modified needle holder.
P960057/S008 6/2/99	ADCON®-L Adhesion Control in a Barrier Gel	Gliatech, Inc. Cleveland, OH 44122	Approval for new quality control measures and is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
P970035/S011 6/3/99	Medtronic AVE S540™ Over-The-Wire Coronary Stent System	Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403	Approval for the Medtronic AVE S540™ Over-The- Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (length £ 24 mm) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2 and 2.9mm. Long term outcome (beyond 30 days) for this permanent implant is unknown at present.
P970038/S002 6/16/99	Tandem®-MP Prostate Specifice Antigen (PSA) Immunoenzymetric Assay	Hybritech, Inc. San Diego, CA 92196	Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Dr., Chaska, MN 55318.
P970038/S003 6/16/99	Tandem®-MP Free PSA Immunoenzymetric Assay	Hybritech, Inc. San Diego, CA 92196	Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318.
P970051/S004 6/9/99	Nucleus 24 Channel Cochlear Implant – CIS and ACE Speech Processing Strategies	Cochlear Corporation Englewood, CO 80112	Approval for Continuous Interleaved Sampling (CIS) and Advanced Combination Encoders (ACE) speech coding strategies.
P970061/S006 6/30/99	31mm SCIMED® RADIUS™ Coronary Stent with Delivery System	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for the 31 mm SCIMED® RADIUS™ Coronary Stent with Over-The-Wire (OTW) and Single-Operator (SOE) Delivery Systems.
P980001/S008 6/11/99	NIR™ Primo™ Premounted Stent System	Boston Scientific Corporation Natick, MA 01760-1537	Approval for a change in the specification of the balloon component for the NIR™ Primo™ Premounted Stent System. This change applies only to the 9 mm length NIR™ Primo™ Premounted Stent System with the 3.0mm, 3.5mm, and 4.0 mm balloon diameters.
P980003/S001 6/14/99	Chilli® Cooled Ablation System for Ischemic Ventricular Tachycardia	Cardiac Pathways Corporation Sunnyvale, CA 94086	Approval of proposed postapproval study for the Chilli® Cooled Ablation System for Ischemic Ventricular Tachycardia.
P980016/S006* 6/16/99	Model 7273 GEM™ II DR Implantable Cardioverter Defibrillator	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM™ and the Model 7273 GEM™ II DR implantable cardioverter defibrillators to correct the premature low battery problem.
P980035/S003* 6/11/99	Medtronic.Vision Model 9953A Series 1.3 Software	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a modification to the Medtronic.Vision Model 9953A Series 1.3 Software, used with the Model 9790 Programmer, to correct a software installation anomaly.

30-DAY NOTICES
APPLICATION NUMBER & LTR DATE	DEVICE NAME	COMPANY NAME	COMMENTS
P880086/S062 6/21/99**	Affinity Family of Pulse Generators	St. Jude Medical	The 30-Day Notice requested elimination of redundant testing in the Affinity pulse generator manufacturing process.

* Evaluated as a "Real-Time Review" PMA Supplement.

**A 135 Day Supplement Was Not Required

Summary of PMA Originals & Supplements Approved

Originals: 2
Supplements: 35

Summary of PMA Originals Under Review

Total Under Review: 80
Total Active: 45
Total On Hold: 35
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 184
Total Active: 123
Total On Hold: 61
Number Greater Than 180 Days: 8

Summary of All PMA Submissions Received
Originals: 9
Supplements: 27

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 35
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 112

Updated 9/9/1999

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Center for Devices and Radiological Health / CDRH

PMA ORIGINAL APPROVALS
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P970018 6/17/99	AutoCyte Prep™	AutoCyte, Inc. Burlington, NC 27216-1029	This device is indicated as a liquid-based, thin-layer cell preparation process. The system produces slides that are intended as replacements for conventional gynecologic Pap smears. AutoCyte PREP slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.
P980022 6/15/99	MiniMed Continuous Monitoring System	MiniMed, Inc. Sylmar, CA 91342	The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace blood glucose information obtained using standard home glucose monitoring devices. The information collected by the device may be downloaded and displayed on a computer and review by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments, which may minimize these excursions.