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FY 2001 ODE Annual Report - Part 2 — Industry Information

Original PMA/HDE Approvals for Fiscal Year 2001

Significant Medical Device Breakthroughs

Devices Approved via PMA/HDE
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Draft Guidance Documents for Comment Purposes Only

 

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/510kClearances/default.htm.

During Fiscal Year 2001, no PDPs were completed, but ODE approved 53 PMAs and 4 HDEs. These are listed below. We recommend turning to the PMA approval website, which is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/default.htm, for easy-to-understand one pagers for each PMA approved.

Original PMA/HDE Approvals for Fiscal Year 2001

   

    COMPANY

         DEVICE


12-Oct-00

P990086

Healthtronics, Inc.

Healthtronics Ossatron

13-Oct-00

P990046

ATS Medical, Inc.

ATS Open Pivot® Bileaflet Heart Valve

16-Oct-00

P000022

Medtronic AVE, Inc.

Medtronic AVE BeStent™ 2 with Discrete Technology™ Over-the-Wire Coronary Stent Delivery System

20-Oct-00

P000015

Cochlear Corp.

Nucleus 24 Auditory Brainstem Implant System

03-Nov-00

P000018

Novoste Corporation

Novoste™ Beta-Cath™ System

03-Nov-00

P990036

Cordis Corporation

Cordis Checkmate™ System

14-Nov-00

P990050

SpectraScience™ , Inc.

Optical Biopsy™ System

22-Nov-00

P990056

Roche Diagnostics Corp.

Elecsys® Total PSA Immunoassay

28-Nov-00

P990081

Ventana Medical Systems, Inc.

PATHWAY™ HER 2 (Clone CB 11)

29-Nov-00

P000020

C.R. Bard, Inc.

Stinger® Ablation Catheter and TempLink® Extension Cable

12-Dec-00

P000027

Roche Diagnostics Corp.

Elecysys® Free PSA Immunoassay

21-Dec-00

P970013

St. Jude Medical, Inc.

Microny™ SR+ Model 2425T Pulse Generator

21-Dec-00

P980020

Q-Care International, LLC

Q-103 Needle Management System

05-Jan-01

P000023

TMJ Implants, Inc.

TMJ Fossa-Eminence/Condylar Prostheses

10-Jan-01

H000001

JOMED AB

JOSTENT® Coronary Stent Graft

24-Jan-01

P980044

Seikagaku, Corp.

SUPARTZ™ Dispo

08-Feb-01

P990043

DiaSorin, Inc.

DiaSorin ETI-EBK PLUS Assay

09-Feb-01

P000016

GE Medical Systems Information Tech.

Corometrics Model 120 F-Series Maternal/Fetal Monitor (Fetal Pulse Oximeter)

16-Feb-01

P990085

VISTAKON, Johnson &
Johnson Vision

VISTAKON (lenefilcon A) Soft Contact Lenses

21-Feb-01

H990013

Ortec International, Inc.

OrCel™ Composite Cultured Skin

27-Feb-01

P000007

Edwards Lifesciences, LLC

Edwards Prima™ Plus Stentless Bioprothesis Model 2500P

27-Feb-0l

P000035

TMJ Implants, Inc.

TMJ Fossa-Eminence Prosthesis™

22-Mar-01

P990026

Cygnus, Inc.

GlucoWatch® Automatic Glucose Biographer

23-Mar-01

H000004

DePuy Orthopaedics, Inc.

PROSTALAC (Prosthesis of Antibiotic-Loaded Acrylic Cement) Hip Temporary Prosthesis

30-Mar-01

P990038

DiaSorin, Inc.

DiaSorin ETI-MAK-2 PLUS Assay

30-Mar-01

P990041

DiaSorin, Inc.

DiaSorin ETI-AB-EBK PLUS Assay

30-Mar-01

P990042

DiaSorin, Inc.

DiaSorin ETI-AB-AUK PLUS Assay

30-Mar-01

P990044

DiaSorin, Inc.

DiaSorin ETI-CORE-IGMK PLUS Assay

30-Mar-01

P990045

DiaSorin, Inc.

DiaSorin ETI-AB-COREK PLUS Assay

05-Apr-01

P990080

Pharmacia & Upjohn Company

CeeOn™ Edge Foldable Ultraviolet-Absorbing Posterior Chamber Intraocular Lens

18-Apr-01

P000046

Anika Therapeutics, Inc.

STAARVISC II Ophthalmic Viscosurgical Device

20-Apr-01

P980048

Sulzer Spine-Tech

BAK/Cervical (BAK/C® ) Interbody Fusion System

20-Apr-01

P000040

BEI Medical Systems, Inc.

Hydro ThermAblator® Endometrial Ablation System

20-Apr-01

P000032

CryoGen, Inc.

HerOption™ Uterine Cryoblation Therapy System

27-Apr-01

P000044

Ortho-Clinical Diagnostics

Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit

30-May-01

P000037

Medical Carbon Research Institute, LLC

ON-X® Prosthetic Heart Valve Model ONXA

01-Jun-01

P990012

Roche Diagnostics Corp.

Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory and Precicontorol HBsAg

05-Jun-01

P000008

BioEnterics Corp.

LAP-BAND® Adjustable Gastric Band

14-Jun-01

P000053

American Medical Systems, Inc.

AMS Sphincter 800™ Urinary Prosthesis

27-Jun-01

P000005

MediTeam AB

Carisolv™ Non-Invasive Dental
Caries Removal System

29-Jun-01

P000043

TherMatrix, Inc.

TMx-2000™ and RX-200 BPH Thermotherapy System

03-Jul-01

P000012

Roche Molecular Systems, Inc.

COBAS AMPLICOR Hepatitis C Virus (HCV) Test

05-Jul-01

P000010

Roche Molecular Systems, Inc.

AMPLICOR Hepatitis C Virus (HCV) Test

05-Jul-01

P000021

Dade Behring, Inc.

Dimension® RxL PSA Flex® Regent Cartridge

12-Jul-01

P000026

STAAR Surgical Company

AquaFlow Collagen Glaucoma Drainage Device

12-Jul-01

P000041

Deus Technologies

RapidScreen™ RS-2000

17-Jul-01

P000055

Ferguson Medical

UBIS 5000 Ultrasound Bone Sonometer

20-Aug-01

P000025

Med-El Corp.

MED-EL COMBI 40+ Cochlear Implant System

28-Aug-01

P010015

Medtronic, Inc.

Medtronic® InSync® Biventricular Pacing System including Model 8040 InSync® Pulse Generator, Attain™ LV Model 2187 and Attain™ CS Model 2188 Leads

28-Aug-01

H010001

Avanta Orthopaedics, Inc.

Metacarpophalangeal Joint Implant Finger Prosthesis

30-Aug-01

P010021

Ortho-Clinical Diagnostics, Inc.

Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and
Calibrators

31-Aug-01

P010016

Ortec International, Inc.

OrCel™ Bilayered Cellular Matrix

07-Sep-01

P010023

SOUNDTEC, Inc.

SOUNDTEC® Direct System

24-Sep-01

P000029

Q-Med AB

Deflux® Injectable Gel

25-Sep-01

P010017

Fisher Imaging, Corp.

SenoScan® Full Field Digital Mammographic X-Ray System

28-Sep-01

P000036

Advanced Tissue Sciences

Dermagraft®

28-Sep-01

P010013

Novacept, Inc.

NovaSure™ Impedance Controlled Thermal Endometrial Ablation Device

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 01. 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)

Novoste™ Beta-Cath™ System by Novoste Corporation (November 3, 2000)

Cordis Checkmate™ System by Cordis Corporation (November 3, 2000)

Heartstream FR2 AED with Attenuated Defibrillation Pads by Agilent Technologies, Inc. (May 2, 2001)

PercuSurge Guardwire Plus by PercuSurge, Inc. a division of Medtronic AVE (June 1, 2001)

Medtronic® InSync® Biventricular Pacing System by Medtronic, Inc. (August 28, 2001)

Model 3100B High Frequency Oscillatory Ventilator by SensorMedics (September 2, 2001)
Division of Clinical Laboratory Devices (DCLD)

GlucoWatch® Automatic Glucose Biographer by Cygnus, Inc. (March 22, 2001)

COBAS Amplicor Hepatitis C Virus (HCV) Test, version 2.0 by Roche Molecular Systems, Inc. (July 3, 2001)

Amplicor Hepatitis C Virus (HCV) Test, version 2.0 by Roche Molecular Systems, Inc. (July 5, 2001)

Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrators by Ortho-Clinical Diagnostics, Inc. (August 30, 2001)
Division of General, Restorative, and Neurological Devices (DGRND)

OrCel™ Bilayered Cellular Matrix by Ortec International, Inc. (February 21, 2001)

OrCel™ Bilayered Cellular Matrix by Ortec International, Inc. (August 31, 2001)

Dermagraft® by Advanced Tissue Sciences (September 28, 2001)

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

AquaFlow Collagen Glaucoma Drainage Device by STAAR Surgical Company (July 12, 2001)

SOUNDTEC® Direct System by SOUNDTEC, Inc. (September 7, 2001)

Division of Reproductive, Abdominal and Radiological Devices (DRARD)

Lap-Band® Adjustable Gastric Banding System by BioEnterics, Corporation (June 5, 2001)

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

DCLD

INSURE Fecal Occult Blood Test by Enterix, Inc. (January 12, 2001)

N Latex Cystatin C by Dade Behring, Inc. (March 13, 2001)

N-Mid Osteocalcin One Step ELISA Model 30SC4000 by Osteometer Biotech A/S (May 16, 2001)

BreathID system for the detection of Helicobacter pylori by Oridion Medical 1987, LTD. (July 9, 2001)

Lipoprotein Test System by Quantimetrix Corp. (July 25, 2001)

DOED

ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens by Cantor & Silver Ltd. of England (October 20, 2000)

OptiFree Express Multipurpose Disinfecting Solution by Alcon Universal Ltd. (October 23, 2000)

SeronoCem™ Otologic Bone Cement by Corinthian Medical, LTD (February 12, 2001)

Oto-Cem™ Bone Cement by Ototech, Inc. (September 13, 2001)

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, 2001)

ODE Guidance Documents

ODE issued 40 guidance documents this Fiscal Year, 29 final and 11 draft, which are listed below. These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/MedicalDevices/default.htm) which provides easy access to the latest information and operating policies and procedures and 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

Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA; Final Guidance for Industry and FDA Staff (November 02, 2000)

Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry (November 30, 2000)

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff (February 28, 2001)

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (May 29, 2001)

Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry (July 12, 2001)


DCRD

Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff (January 31, 2001)

Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adapter 510(k) Submissions (November 1, 2000)

Guidance Document for Vascular Prostheses 510(k) Submissions (November 1, 2000)

Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final

Guidance for Industry and FDA Staff (November 13, 2000)

Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions;

Final Guidance for Industry and FDA (November 29, 2000)

Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final

Guidance for Industry and FDA (November 29, 2000)

Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers (November 8, 2000)


DCLD

Guidance for Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells (November 1, 2000)

Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers (November 30, 2000)

Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (lgE) 510(k)s; Final Guidance for Industry and FDA (August 22, 2001)


DDIGD

Guidance on Premarket Notifications for Intravascular Administration Sets (October 12, 2000)

Premarket Approval Application (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA (March 2, 2001)

Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA (March 12, 2001)


DGRND

Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented Prosthesis (October 31, 2000)

Guidance for Neurological Embolization Devices (November 1, 2000)

Guidance Document for Dura Substitute Devices (November 9, 2000)

Class II Special Controls Guidance: Polymethylmethacrylate (PMMA) Bone Cement 510(k)s (August 2, 2001)

Guidance for Saline, Silicone Gel, and Alternative Breast Implants (August 13, 2001)


DOED

Information for Keratome Manufacturers regarding LASIK; Final Guidance for Industry (June 21, 2001)


DRARD

Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers (January 16, 2001)

Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA (February 16, 2001)

Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers (March 9, 2001)

Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers (May 16, 2001)

Bone Sonometer PMA Applications; Final Guidance for Industry and FDA (June 21, 2001)


- Draft Guidance Documents for Comment Purposes Only

Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications (November 14, 2000)

Draft Guidance for Prescription Use of Drugs of Abuse Assays Premarket Notifications (November 14, 2000)

Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA (March 1, 20001)

Premarket Approval Applications for In-Vitro Diagnostic Devices Pertaining to Hepatitis C Virus (HCV): Assays Intended for Diagnosis, Prognosis or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for Industry and FDA (April 27, 2001)

The Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept and Principles; Draft Guidance for FDA and Industry (May 3, 2001)

Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities (May 21, 2001)

Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff (June 21, 2001)

Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff (July 18, 2001)

A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Draft Guidance for Industry and FDA Staff (July 25, 2001)

Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Draft Guidance for Industry and FDA (August 15, 2001)

Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis (September 6, 2001)