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FY 2002 ODE Annual Report - Part 2 - Industry Information

Original PMA/HDE Approvals for Fiscal Year 2002
Significant Medical Device Approvals

PMA/HDE Approved Devices
510(k) Clearances or Automatic Evaluations of Class III Designation Devices
ODE Guidance Documents
Final Guidance Documents Adopted
Draft Guidance Documents for Comment Purposes Only
FDA Industry Website

ODE reviews four major types of marketing applications: Premarket Notification (i.e., a 510(k) submission), Premarket Approval Application (PMA), Product Development Protocol (PDP), and Humanitarian Device Exemption (HDE). Devices cleared for marketing through the 510(k) process are too numerous to list here but can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm

During Fiscal Year 2002, no PDPs were completed, but ODE approved 41 PMAs and 6 HDEs. These are listed below. We recommend turning to the PMA approval website, which is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm, for easy-to-understand one pagers for each PMA approved.

 Original PMA/HDE Approvals for Fiscal Year 2002

   

     COMPANY

             DEVICE

       
11-Oct-01 P010019 CIBA Vision Corporation Focus® Night & Day™
12-Oct-01 P000030 CIBA Vision Corporation Focus® Night & Day™
17-Oct-01 H010002 Stryker Biotech OP-1™ Implant
02-Nov-01 P000052 Guidant Corp. GALILEO™ Intravascular Radiotherapy System
09-Nov-01 P010007 Diagnostic Products Corporation Immulite/Immulite 2000 AFP
16-Nov-01 P980033 Boston Scientific Scimed, Inc. WALLSTENT® Venous Endoprosthesis with Unistep™ Plus RP Delivery System (10mm Venous Endoprothesis) WALLSTENT® Venous Endoprosthesis with Unistep™ Plus Delivery System (12mm-16mm Venous Endoprotheses)
16-Nov-01 P990015 Lifecore Biomedical, Inc. Intergel (Adhesion Prevention Solution)
19-Nov-01 P000057 Ascension Orthopedics, Inc. Ascension MCP
21-Nov-01 P010027 Ophthalmic Innovations Int’l Inc. Allergan, Inc. Model AC21B Ultra
21-Nov-01 P010032 Advanced Neuromodulation System, Inc. Genesis Neurostimulation (IPG) System
28-Nov-01 P010033 Cellestis Limited QuantiFERON - TB
03-Dec-01 P010003 CryoLife, Inc. Bioglue® Surgical Adhesive
05-Dec-01 P000039 AGA Medical Corporation AMPLATZER® Septal Occluder (ASO) & the AMPLATZER® Exchange System
05-Dec-01 P000049 Nitinol Medical Technologies, Inc. CardioSEAL® Septal Occlusion System with QuikLoad™
14-Dec-01 P010022 Cohesion Technologies, Inc. CoSeal™ Surgical Sealant
18-Dec-01 P010020 American Medical Systems, Inc. AMC Acticon Neosphincter (Fecal Incontinence Device)
18-Dec-01 P010030 Lifecore, Inc. WCD® 2000 System
19-Dec-01 H000002 VISX, Inc. VISX Custom Cornea Ablation Pattern
15-Jan-02 P000048 Dornier Medtech America, Inc. Dornier Epos Ultra
15-Jan-02 P010038 Intelligent Systems Software, Inc. Mammoreader(Computer-Aided Detection System)
       
31-Jan-02 P010034 CADx Medical Systems Inc. Parexel Intl. Corp Second Look ™ (Computer-Aided Detection System for Mammography
28-Feb-02 P010054 Roche Diagnostics Corporation Elecsys Anti-HBs Immunoassay
05-Mar-02 P990065 Sirtex Medical Limited Matrix Medical Consulting Corp. Sir-Spheres (Radionuclide Microspheres)
14-Mar-02 P010043 Yama, Inc. Lea’s Shield Barrier Contraceptive
15-Mar-02 P010025 Hologic, Inc. Lorad Digital Breast Imager (Full Field Digital System, X-Ray, Mammographic)
15-Mar-02 P010040 Safeguard Medical Devices, Inc. The “Disintegrator” Insulin Needle Destruction Device
22-Mar-02 H010005 Ascension Orthopedics, Inc. Ascension® PIP
25-Mar-02 P010049 SUB-Q, Inc. QuickSeal™ Femoral Arterial Closure System
03-Apr-02 P000033 Sulzer IntraTherapeutics, Inc. IntraCoil® Self-Expanding Peripheral Stent
05-Apr-02 H000007 AGA Medical Corporation AMPLATZER® PFO Occluder
11-Apr-02 P010018 Refratec, Inc. ViewPoint™ CK System
02-May-02 P010012 Guidant Corporation CONTAK CD® CRT-D (Cardiac Resynchronization Therapy Defibrillator) System and EASYTRAK Coronary Venous Steroid-Eluding Single-Electrode Pace/Sense Lead, Models 4510, 4511, 4512, 4513
22-May-02 P010002 U.S. Surgical Corp. Indermil™ Tissue Adhesive
13-Jun-02 P000028 Medtronic Sofamor Danek, Inc. Affinity™ Cage System
24-Jun-02 P010041 Edwards Lifesciences, LLC Carpentier-Edwards S.A.V. Bioprosthesis, Model 2650 (Aortic)
26-Jun-02 P010031 Medtronic, Inc. Insync® ICD 7272 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and the Model 9969 Application Software
02-Jul-02 P000058 Medtronic Sofamor Danek, Inc. Infuse Bone Graft/Lt-Cage Lumbar Tapered Fusion Device
19-Jul-02 P010039 Siemens Medical Solutions USA, Inc. Siemens Sonocur Basic System
19-Jul-02 P020003 Mentor Corporation Mentor Saline-Filled Testicular Prosthesis
22-Jul-02 P010052 Diagnostic Products Corporation IMMULITE®/IMMULITE® 2000 Anti-HBs
24-Jul-02 P010051 Diagnostic Products Corporation IMMULITE®/IMMULITE® 2000 Anti-HBc
26-Jul-02 P010050 Diagnostic Products Corporation IMMULITE®/IMMULITE® 2000 HBsAG
26-Jul-02 P010053 Diagnostic Products Corporation IMMULITE®/IMMULITE® 2000 Anti-HBcIgM
09-Aug-02 H010004 Guidant Corp. NEUROLINK® System
09-Sep-02 H020002 SMART Therapeutics, Inc. Neuroform™ Microdelivery Stent System
11-Sep-02 P020009 Boston Scientific Scimed, Inc. Express™ and Express2™ Monorail and Over-the-Wire Coronary Stent Systems
27-Sep-02 P010068 Biosense Webster, Inc. NaviStar/Celsius DS Diagnostic/Ablation Deflectable 8mmTip Catheter

 Significant Medical Device Approvals

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 02. 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.

 - PMA/HDE Approved Devices


Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID)

  • Univec Bifurcated Sliding Sheath Syringe, by Univee, Inc. (March 19, 2002)
  • BD Bifurcated Needle, by Becton, Dickerson, Inc. (March 20, 2002)


Division of Cardiovascular Devices (DCD)

  • Wearable Cardioverter Defibrillator (WCD®) 2000 System by Lifecore, Inc. (December 18, 2001)
  • IntraCoil® Self-Expanding Peripheral Stent by Sulzer IntraTherapeutics, Inc. (April 3, 2002)
  • CONTAK CD® CRT-D (Cardiac Resynchronization Therapy Defibrillator) System and EASYTRAK Coronary Venous Steroid-Eluding Single-Electrode Pace/Sense Lead by Guidant Corporation (May 2, 2002)
  • Insync® ICD 7272 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and the Model 9969 Application Software by Medtronic, Inc. (June 26, 2002)
  • Cordis PALMAZ® Balloon Expandable Stent (renal stent) by Cordis Corporation (July 10, 2002)
  • Ventak Prizm 2 VR/DR, Ventak Prizm VR/DR, Ventak Prizm VR/DR HE, Ventak Mini IV and Ventak Mini III HE by Guidant Corporation (July 18, 2002)

Division of Clinical Laboratory Devices (DCLD)

  • QuantiFERON-TB by Cellestis Limited (November 28, 2001)
  • Division of General, Restorative, and Neurological Devices (DGRND)
  • Infuse Bone Graft/Lt-Cage Lumbar Tapered Fusion Device by Medtronic Sofamor Danek, Inc. (July 7, 2002)
  • Neurolink® System by Guidant Corp. (August 9, 2002)
  • Neuroform™ Microdelivery Stent System by Smart Therapeutics, Inc.
    (September 9, 2002)


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

  • Focus® Night & Day™ soft contact lens by CIBA Vision Corporation (October 11, 2001)
  • PureVison™ (balafilcon A) Visibility Tinted Contact Lens by Bausch and Lomb Vision Care (November 20, 2001)
  • Paragon CRT™ and Quadra RG™ Rigid Gas Permeable Contact Lenses for Refractive Therapy by Paragon Vision Sciences (June 13, 2002)
  • Menicon Z™ Rigid Gas Permeable Contact Lens (for up to 30 days of wear) by Menicon Co., Ltd. (July 12, 2002)
  • Division of Reproductive, Abdominal and Radiological Devices (DRARD)
  • Mentor Saline-Filled Testicular Prosthesis by Mentor Corporation (July 21, 2002)


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

DCLD

  • RIA Cocaine Assay by Psychemedics Corporation (November 6, 2001)
  • RIA Methamphetamine and MDMA Assay by Psychemedics Corporation (January 23, 2002)
  • RIA Phencyclidine Assay by Psychemedics Corporation (February 8, 2002)
  • QUANTA LITE IgG anti-CCP Assay by Inova Diagnostics, Inc. (April 29, 2002)
  • RIA Cannabinoid Assay by Psychemedics Corporation (May 3, 2002)
  • Accu-Chek Advantage Module by Roche Diagnostics (June 2, 2002)
  • Freestyle Tracker Diabetes Management System by ThersaSense, Inc. (June 2, 2002)
  • DIASTAT Anti-CCP Assay by Axis-Shield, Inc. (July 23, 2002)
  • QUANTA Lite SLA Assay by Inova Diagnostics, Inc. (July 30, 2002)
  • QUANTA Lite Actin Assay by Inova Diagnostics, Inc. (September 20, 2002)
  • Automated Cellular Imaging System (ACIS) for Estrogen and Progesterone Receptors by ChromaVision Medical Systems, Inc. (September 30, 2002)


DOED

  • Artificial Cornea by Argus Biomedical Pty Ltd. (August 29, 2002)


DRARD

  • Given® Diagnostic Imaging System (1st swallowable capsule containing a tiny video camera that takes pictures of the entire small bowel) by Given Imaging Ltd. (August 1, 2002)

 ODE Guidance Documents

ODE issued 2 Blue Book Guidance Memoranda and 22 other guidance documents this Fiscal Year, 15 final and 9 draft, which are listed below. Of the 24 total in FY02, 15 are Special Controls guidance, 9 final and 6 draft. These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/cdrh) which provides easy access to the latest information and operating policies and procedures. They may also be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041 or 301-443-6597; fax 301-443-8818; Email dsmica@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307.) Many guidance documents are also available through the CDRH Facts-On-Demand (faxback service at 800-899-0381 or 301-837-0111).

 - Final Guidance Documents Adopted

ODE

Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices (Blue Book Guidance Memorandum #D01-1, October 26, 2001)

Fax & E-mail Communication with Industry about Premarket Files Under Review (Blue Book Guidance Memorandum #A02-01, March 1, 2002)

Updated 510(k) Sterility Review Guidance; Final Guidance for Industry and FDA (K90-1, August 30, 2002)

DCD

Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry (July 1, 2002)

DCLD

Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA (December 4, 2001)

Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA (September 16, 2002)

DAGID

Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA (October 5, 2001)

Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff (February 7, 2002)

Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA (July 17, 2002)

Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA (August 30, 2002)

DGRND

Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA (April 30, 2002)

Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA (July 17, 2002)

DOED

Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry and FDA (April 29, 2002)

DRARD

Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA (November 28, 2001)

Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry (June 18, 2002)
- Draft Guidance Documents for Comment Purposes Only

Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Draft Guidance for Industry and FDA (February 7, 2002)

Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA (February 12, 2002)

Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA (February 20, 2002)

Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)

Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Draft Guidance for Industry and FDA (April 5, 2002)

Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA (May 14, 2002)

 

Implantable Middle Ear Hearing Device; Draft Guidance For Industry and FDA (June 12, 2002)

Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers (August 14, 2002)

Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer dl-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA (September 6, 2002)

 FDA Industry Website

At the end of FY 02, FDA launched a new portal page on its Website to make it easier for FDA-regulated companies to find information they need to comply with regulations. Featured links on the page include:

  • Guidance documents,
  • Inspection references,
  • Information on imports,
  • Warning letters and other FDA enforcement activities.

The portal also provides easy access to regulatory information from FDA’s centers. Companies can use the portal to contact FDA with questions, submit comments online about proposed FDA regulations, or sign up to attend meetings for which registration is required.

The new portal is at http://www.fda.gov/ForIndustry/default.htm.