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Draft Guidance Documents for Comment Purposes Only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 (1^st 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)