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FY 2000 ODE Annual Report - Part 2 – Industry Information

Original PMA/HDE Approvals for Fiscal Year 2000
Significant Medical Device Breakthroughs

Devices Approved via PMA/HDE
510(k) Clearances or Automatic Evaluations of Class III Designation Devices (AE)

ODE Guidance Documents
Draft Guidance Documents on the Internet for Comment Purposes Only

ODE reviews four types of marketing applications: Premarket Notification (or a 510(k) submission), Premarket Approval Application (PMA), Product Development Protocol (PDP), and Humanitarian Device Exemption (HDE). Most devices are cleared for marketing through the 510(k) process. PMAs apply to the highest risk and newly developed devices.

During Fiscal Year 2000, ODE approved 43 PMAs and 6 HDEs. These are listed below. We recommend turning to the new PMA approval website, which is available at the Recently Approved Devices web page, for easy-to-understand one pagers for each PMA approved.

Original PMA/HDE Approvals for Fiscal Year 2000

25-Oct-99P990033Ceramed Corp.PEPGEN P-15 Bone Filling Augmentation
12-Nov-99P980008LaserSightLaserScan LSX for PRK myopia
12-Nov-99P990014Bausch & Lomb
Surgical, Inc.
Hydroview Composite Hydrogel Foldable
Ultraviolet (UV) -Absorbing Posterior
Chamber Intraocular Lens (IOL)
19-Nov-99P990010VISXVISX Star S2 for LASIK myopia plus astigmatism
Pharmaceuticals, Inc.
Photodynamic Therapy
03-Dec-99P990009Fusion Medical
Technologies, Inc.
Hemostatic Agent
07-Dec-99H990007CryoLife, Inc.BioGlue®Surgical Adhesive
10-Dec-99H980006DataMedix Corp.Therasphere®
16-Dec-99P970049DishlerDishler Excimer for LASIK myopia plus astigmatism
07-Jan-00P990016McCue Corp., Inc.Ultrasonic Bone Sonometry System
20-Jan-00P990035Sunlight Ultrasound
Technologies, Inc.
Ultrasonic Bone Sonometry System
28-Jan-00P990066GE Medical SystemSenographe 2000D (1st digital mammography)
01-Feb-00H990011Nitinol Medical.
Technologies, Inc
CardioSEAL® Septal Occlusion System
03-Feb-00P980040Allergan, Inc.Sensar Soft Acrylic UV-Absorbing Posterior
Chamber IOL
23-Feb-00P990027Bausch & LombTechnolas 217A for LASIK myopia
24-Feb-00P990023Alcon LaboratoriesCellugel Ophthalmic Viscosurgical Device
09-Mar-00H990008Interpore Cross
Telescopic Plate Spacer (TPS) Spinal System
17-Mar-00P990054Cardiac Pathways Corp.CHILLI COOLED ABLATION SYSTEM with
31-Mar-00H990014Medtronic, Inc.Gastric Electrical Stimulation System
(Now known as Enterraä Therapy System)
02-Apr-00P990013Star Surgical, Co.IOL
12-Apr-00P990048Carl ZeissVISULAS 690s Laser and VISULINK PDT adapter
12-Apr-00P990049Coherent Medical GroupCoherent Opal Photoactivator and modified Coherent LaserLink
18-Apr-00P950020Interventional Technologies, Inc.Cutting Balloon
10-May-00P990074McGhan Medical Corp.RTV Saline-Filled Breast Implant
10-May-00P990075Mentor CorporationSaline-Filled and Spectrum® Mammary Prosthesis
11-May-00H990012Cardiovascular Diagnostics, Inc.TAS Ecarin Clotting Time Test
12-May-00P990053Nellcor Puritan Bennett, Inc.Oxifirst Fetal Oxygen Saturation Monitor
26-May-00P990028Focal Inc.FocalSeal-L Synthetic Absorbable Surgical Sealant
31-May-00P990071Biosense Webster, Inc.Stockert 70 RF Generator for Cardiac Ablation
13-Jun-00P990030Cohesion Technologies, Inc.CoStasis Surgical Hemostar
14-Jun-00P980050Medtronic, Inc.Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter Defibrillator, Model 9961 Programmer Application Software and Medtronic® Sprint Model 6943 Steroid Eluting, Screw-in, Atrial/Ventricular Lead
15-Jun-00P990025Biosense Webster, Inc.NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter
22-Jun-00P990037Vascular Solutions, IncVascular Solutions Duett Sealing Device
30-Jun-00P990021QLT Photo Therapeutics, Inc.Diomed 630 PDT Laser, Model T
30-Jun-00P990078SunriseHyperion LTK for hyperopia
11-Jul-00P990018Menicon U.S.A.Minicon(tisilfocon A) Rigid
14-Jul-00P990064Medtronic, Inc.MOSAIC® Porcine Bioprosthesis, Models 301 and 310
21-Jul-00P990034Medtronic, Inc.Medtronic Isomed Infusion System
24-Jul-00P000006Mentor Corp.Alpha I Inflatable Penile Prosthesis
01-Aug-00P990039Metra BiosystemsQUS-2 Calcaneal Ultrasonometer
22-Aug-00P990072Westcon Contact Lens Co., Inc.Horizon 55 EW and Horizon 55
31-Aug-00P990052Symphonix Devices, Inc.Vibrant P Soundbridge System
05-Sep-00P970042Medstone International, Inc.Medstone STS Lithotripter
08-Sep-00P990055Bayer Corp.Bayer Immuno 1 Complexed PSA Assay
19-Sep-00P980010Ostenometer MediTech, Inc.DTU-one Ultrasound Scanner
25-Sep-00P990040Cordis Neuro- vascular Inc.TRUFILL®n-Butyl Cyanoacrylate (nBCA) Liquid
Embolic System
29-Sep-00P000014Ortho-Clinical Diagnostics, Inc.VITROS Immunodiagnostic Products:Anti-HBS Reagent Pack/Anti-HBS Calibrators
29-Sep-00P000009Biotronik, Inc.Phylax AV Implantable Cardioverter Defibrillator with Program Software (I-GAV.2.U)
29-Sep-00P000011Biocompatibles Cardiovascular, Inc.BiodivYsio AS PC (phosphorylcholine) Coated Stent
and Delivery System

Significant Medical Device Breakthroughs

The following devices were approved via PMAs, PMA Supplements, and HDEs or cleared via 510(k)s or classified via the Automatic Evaluation of Class III Designation process during FY 00. They represent significant medical breakthroughs because they are first-of-a-kind, e.g., they use a new technology or energy source, or they provide a major diagnostic or therapeutic advancement, such as reducing hospital stays, replacing the need for surgical intervention, reducing the time needed for a diagnostic determination, etc. The information for each device includes the trade name and/or classification name, firm, and date of approval or clearance.

Devices Approved via PMA/HDE

Division of Cardiovascular and Respiratory Devices (DCRD)

Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter Defibrillator by Medtronic, Inc. (June 14, 2000)

NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter by Biosense Webster, Inc. (June 15, 2000)

Division of Clinical Laboratory Devices (DCLD)

TAS Ecarin Clotting Time Test by Cardiovascular Diagnostics, Inc. (May 11, 2000)

Division of General, Restorative, and Neurological Devices (DGRND)

RTV Saline-Filled Breast Implant by McGhan Medical Corp. (May 10, 2000)

Saline-Filled and Spectrum® Mammary Prosthesis by Mentor Corporation (May 10, 2000)

FocalSeal-L Synthetic Absorbable Surgical Sealant by Focal Inc. (May 26, 2000)

Apligraf® (Graftskin) by Organogenesis Inc. (June 20, 2000)

TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System by Cordis Neurovascular Inc. (September 25, 2000)

Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED)

Hyperion® for Laser Thermal Keratoplasty for Hyperopia (+0.75 to +2.5 diopters) by Sunrise Technologies (June 30, 2000)

Vibrant Soundbridge by Symphonix Devices, Inc. (August 31, 2000)

Division of Reproductive, Abdominal and Radiological Devices (DRARD)

Senographe 2000D (1st digital mammography) by GE Medical System (January 28, 2000)

Gastric Electrical Stimulation System by Medtronic, Inc. (March 31, 2000)

Oxifirst Fetal Oxygen Saturation Monitor by Nellcor Puritan Bennett, Inc. (May 12, 2000)

Alpha I Inflatable Penile Prosthesis by Mentor Corp. (July 14, 2000)

Medstone STS Lithotripter by Medstone International, Inc. (September 5, 2000)

510(k) Clearances or Automatic Evaluations of Class III Designation Devices (AE)


Becton, Dickinson & Co.’s Probetec ET System for Chlamydia Trachomatis and Gonorrhea (November 4, 1999)

Wallac Neonatal Biotinidase Test Kit by Perkin Elmer Inc. (November 22, 1999)

Axix %CDT Turbidometric Immunoassay by Axis (December 21, 1999)

MTM Bioscanner HDL Test Strips (Over-the-Counter) by Polymer Technology Systems, Inc. (January 13, 2000)

CDC’s Synthetic VDRL Antigen Slide for Syphilis (February 23, 2000)

Cedia Dau Amphassure Assay by Microgenics Corporation (May 2, 2000)

BV Blue by Gryphus Diagnostics, L.L.C. (May 15, 2000)

Bioscanner Triglycerides Test Strips by Polymer Technology Systems, Inc. (May 24, 2000)


Microwave Delivery System (MDS), Model MMC-3000 by Microwave Medical, Inc. (October 1, 1999)

600 C Laser Keratome by IntraLase Corporation (December 17, 1999)

Excimer Laser Phototherapy System AL7000 by AccuLase, Inc. (January 27, 2000)

Visage Cosmetic Surgery Model V5000 by ArthroCare Corporation (March 20, 2000)

CSM Stretta System by Conway Stuart Medical Inc. (April 18, 2000)

Laser Photolysis System and Pharo Opthalmic Surgery System by A.R.C. Laser Corporation (June 29, 2000)

da Vinci Endoscopic Instrument Control System and Endoscopic Instruments by Intuitive Surgical, Inc. (July 11, 2000)


Purilens System contact lens cleaning and disinfection system by Purilens, Inc. (October 1, 1999)

Ocu-flex-38 Keratoconus (polymacon) soft contact lens by Ocu-Ease Optical Products, (October 4, 1999)

Hylashield CL contact lens lubricating eye drop by Biomatrix, Inc. (March 2, 2000)

Hylasine, hylan B Gel by Biomatrix, Inc. (March 13, 2000)

VISX WaveScan Wavefront Analysis System Refractometer (April 28, 2000)

Autononmous Technologies CustomCornea Wavefront Analysis Refractometer (May 16, 2000)

Sportsight GP rigid gas permeable contact lens by Paragon Vision Sciences, (May 22, 2000)

Option care system for cleaning and disinfecting non-UV absorbing contact lenses by Optisonic, Inc. (June 5, 2000)

MeroGel Otologic pack by Medtronic Xomed (July 3, 2000)


LifeSite® Hemodialysis Access System by Vasca, Inc. (August 24, 2000)

ODE Guidance Documents

The following guidance documents were adopted by ODE and its operating divisions during FY 00 and are available from the Division of Small Manufacturers Assistance (DSMA, HFZ-200). To contact DSMA, call 800-638-2041 or 301-443-6597; fax 301-443-8818; Email or write to DSMA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307.)

Many are also available through the CDRH Facts-On-Demand (faxback service at 800-899-0381 or 301-837-0111) and the World Wide Web (CDRH homepage: which provide easy access to the latest information and operating policies and procedures.


Use of Standards in Substantial Equivalence Determinations (March 13, 2000)


Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s (July 22, 2000)

Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)s (July 22, 2000)

Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notification (August 23, 2000)


Guidance for Cardiovascular Intravascular Filter Submissions (November 26, 1999)

Guidance for Annuloplasty Rings 510(k) Submissions (November 26,1999)

Guidance for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer (January 24, 2000)

Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions (February 21, 2000)

Guidance for Electrical Safety, Electromagnetic Compatibility, Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions (June 28, 2000)

Class II Special Control Guidance for Acute Upper Airway Obstruction Devices (July 3, 2000)

One Consolidated Annual Report for a Device Product Line (1-CARD): Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval Applications (July 6, 2000)

Draft Guidance for Infant/Child Apnea Monitor 510(k) Submissions (September 22, 2000)


Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses (October 5, 1999)

Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery (December 16, 1999)

Guidance Document for the Preparation of IDEs for Spinal Systems (January 13, 2000)

Guidance for Surgical Suture 510(k)s (August 10, 2000)

Guidance for Spinal System 510(k)s (September 27, 2000)


Intraocular Lens Guidance Document (draft) (October 14, 1999)

Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses (April 10, 2000)

Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications (draft) (August 1, 2000)


Draft Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery (December 16, 1999)

Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final (January 16, 2000)

Class II Special Controls Guidance Document for Clinical Engorgement Devices (July 3, 2000)

Guidance for the Submission of Premarket Notifications for Medical Image Management Devices (July 27, 2000) (update of PACS guidance, DSMA FOD#416)

Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources (August 2, 2000)

Draft Guidance Documents on the Internet for Comment Purposes Only

Guidance on Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) that are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease (October 8, 1999)

Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (December 21, 1999)

Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices (March 8, 2000)

Revision to the Extracorporeal Shockwave Lithotripter Guidance (August 9, 2000)

Guidance for Administrative Procedures for CLIA Categorization (August 14, 2000)

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