FY 2003 ODE/OIVD Annual Report - Part 2 - Industry Information

ODE/OIVD review 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 2003, no PDPs were completed, but ODE/OIVD approved 31 PMAs and 2 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 2003

		COMPANY	DEVICE
04-Nov-02	P020014	Conceptus, Inc.	Essure System (Contraceptive Tubal Occlusion Device)
06-Nov-02	P020004	W. L. Gore & Associates, Inc.	EXCLUDER™ Bifurcated Endoprosthesis
07-Nov-02	P020011	Gen-Probe, Inc.	Versant™ HCV RNA Qualitative Assay
27-Nov-02	P990069	EPMedSystems, Inc.	ALERT® System
12-Dec-02	P020008	Karl Storz Endoscopy-America, Inc.	Karl Storz Autofluorescence System
18-Dec-02	P020007	Medtronic, Inc.	Medtronic AVE Bridge™ Extra Support Over-the-Wire (OTW) Renal Stent System
23-Dec-02	P010055	Prostalund Operations AB	ProstaLund CoreTherm System Microwave Thermotherapy for BPH (Benign Prostatic Hyperplasia)
03-Jan-03	P020028	Phillips Medical Systems, Inc	Series 50 XMO Fetal/Maternal Monitor (Model M1350C) with Integrated Fetal Oxygen Monitoring (Fetal Oximeter)
24-Jan-03	P020027	Dade Behring, Inc.	Dimension FPSA Flex Reagent Cartridge and Dimension T/F PSA
03-Feb-03	P010001	Ceramtec AG	Ceramic Transcend Hip Articulation System
03-Feb-03	P000013	Howmedica Osteonics Corp.	Osteonics ABC System and Trident Ceramic System
14-Mar-03	P010065	E MED Future	Needle Zap™
28-Mar-03	P020022	Bayer Corp.	Bayer Versant™ HCV RNA 3.0 Assay
28-Mar-03	P020041	FemCap Incorporated	FemCap™ Barrier Contraceptive
15-Apr-03	H020007	Medtronic, Inc.	Medtronic Activa® Dystonia Therapy
17-Apr-03	P020045	CryoCath Technologies Inc.	7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System
22-Apr-03	P020006	Enteric Medical Technologies, Inc.	Enteryx™ Procedure Kit
24-Apr-03	P020026	Cordis Corporation	CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR™ Over- the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System
07-May-03	P020052	St. Jude Medical	Response™ CV Catheter System
14-May-03	P020024	AGA Medical Corporation	AMPLATZER® Duct Occluder and 180° Delivery System
23-May-03	P020018	Cook Incorporated	Zenith® AAA Endovascular Graft and H&L-B One-Shot Introduction System
06-Jun-03	P020002	Cytyc Corp.	ThinPrep™ Imaging System
11-Jun-03	P020037	Guidant Corp.	FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
07-Jul-03	P030027	Wright Medical Technology, Inc.	Ceramic Transcend Hip Articulation
07-Jul-03	H020004	Smith and Nephew Wound Management	Dermagraft®
16-Jul-03	P020047	Guidant Corporation	MULTI-LINK RX and OTW VISION™ Coronary Stent Systems
29-Jul-03	P020049	Hancock Jaffe Laboratories, Inc.	ProCol® Vascular Bioprosthesis
01-Aug-03	P020021	AXCAN Scandipharm, Inc.	Wizard X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser
12-Aug-03	P020036	Cordis Corporation	S.M.A.R.T.TM and S.M.A.R.T.TM ControlTM Nitinol Stent System
13-Aug-03	P020033	Independence Technology, L.L.C.	INDEPENDENCE™ iBOT™ 3000 Mobility System
25-Aug-03	P020025	Boston Scientific	EP Technologies EPT-1000 XPä RF Ablation System
23-Sep-03	P020031	Microsulis Medical, Ltd.	Microwave Endometrial Ablation System (Thermal Endometrial Ablation Device)
30-Sep-03	P020035	X-Site Medical, L.L.C.	X-PRESS™ 6 French Vascular Closure System

 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 03. 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.

 - ODE PMA/HDE Approved Devices

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

NeedleZap™ by E MED Future (March 14, 2003)

Division of Cardiovascular Devices (DCD)

Thoratec HeartMate® SNAP-VE LVAS (Sutures Not Applied-Vented Electric Left Ventricular Assist System) by Thoratec Corporation (November 6, 2002)

CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System; CYPHER™ Sirolimus-eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System by Cordis Corporation (April 24, 2003)

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

Ceramic Transcend Hip Articulation System by Ceramtec AG (February 3, 2003)

Osteonics ABC System and Trident Ceramic System by Howmedica Osteonics Corp.
(February 3, 2003)

Medtronic Activa® Deep Brain Stimulation (DBS) System by Medtronic, Inc. (April 15, 2003)

INDEPENDENCE™ iBOT™ 3000 Mobility System by Independence Technology, L.L.C. (August 13, 2003)

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

LADARVision® 4000 Excimer Laser System by Alcon Laboratories, Inc. (October 18, 2002)

STAR S4 ActiveTrak™ Excimer Laser System and WaveScan WaveFront® System by VISX, Inc. (May 23, 2003)

Division of Reproductive, Abdominal and Radiological Devices (DRARD)

The Essure™ System by Conceptus, Inc. (November 4, 2002)

 

 - OIVD PMA/HDE Approved Device

ThinPrep™ Imaging System by Cytye Corporation (June 6, 2003)

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

DDIGD

Reactive Skin Decontamination Lotion (RSDL) by O’Dell Engineering Ltd./E-Z-EM Canada Inc. (March 25, 2003)

DGRND

Repiphysis Limb Salvage System by Wright Medical Technology, Inc. (December 4, 2002)

TenoFix Tendon Repair System by Ortheon Medical Llc. (January 22, 2003)

DOED

TGDc-01 “PRA” Tonometer by Truvision Instruments (October 11, 2002)

MP-1 Micro Perimeter by Nidek Technologies (December 23, 2002)

DRARD

Embosphere Microspheres and Embogold Micropheres by Biosphere Medical, Inc. (November 22, 2002)

Contour Emboli Pva and Fastracker-325 Infusion Catheter by Boston Scientific Corp.
(September 23, 2003)

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

Group B Streptococcus Detection Assay by Infectio Diagnostic, Inc. (November 18, 2002)

QCS Her/2 Immunocontrols by OC Sciences (June 18, 2003)

 ODE Guidance Documents

In FY 03, ODE and OIVD issued 3 Blue Book Guidance Memoranda and 28 other guidance documents, 22 final and 6 draft, which are listed below. Of the total, 7 are related to the implementation of MDUFMA. Of the 28, 12 are Special Controls guidance, 10 final and 3 draft. 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. 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 dsma@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).

- ODE and OIVD Final Guidance Documents Adopted

ODE/OIVD

The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry (October 4, 2002)

ODE/OIVD MDUFMA Guidance Documents Adopted

Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1). This guidance has been updated to reflect the change made by section 208 of MDUFMA (December 3, 2002)

Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA (February 25, 2003)

Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New Section 502(f) of the Federal Food, Drug and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities (Blue Book Guidance Memorandum #G03-1, March 31, 2003)

Premarket Approval Application Filing Review - Guidance for Industry and FDA Staff (May 1, 2003)

Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff, (June 3, 2003)

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices - Guidance for Industry and FDA Staff, (July 8, 2003)

Premarket Assessment of Pediatric Medical Devices - Draft Guidance for Industry and FDA Staff, (July 24, 2003)

 - ODE Final Guidance Documents Adopted

ODE

Intercenter Consultative/Collaborative Review Process (Blue Book Guidance Memorandum #G02-1, October 3, 2002)

A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff (June 26, 2003)

DCD

Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff (July 15, 2003)

DAGID

Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA (November 12, 2002)

Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (Pc02) Monitors; Guidance for Industry and FDA (December 13, 2002)

Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA (December 31, 2002)

Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA (April 22, 2003)

DGRND

Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA (January 16, 2003)

Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA (February 11, 2003)

Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Final Guidance for Industry and FDA (June 2, 2003)

Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA (June 3, 2003; Draft Issued December 19, 2002)

DOED

Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA (November 7, 2002)

Guidance for Industry and FDA Staff Implantable Middle Ear Hearing Device
(August 1, 2003)

 

DRARD

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices – Guidance for Industry and FDA Staff (July 14, 2003)

Class 11 Special Controls Guidance Document: Breast Lesion Documentation System – Guidance for Industry and FDA Staff (July 28, 2003)

- OIVD Final Guidance Documents Adopted

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA Staff (February 5, 2003)

Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry (February 26, 2003)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff (June 19, 2003)

Class II Special Controls Guidance Document: Breath Nitric Oxide Test System - Guidance for Industry and FDA Staff (July 7, 2003)

 - ODE Draft Guidance Documents for Comment Purposes Only

Class II Special Controls Guidance Document: Processed Human Dura Mater; Draft Guidance for Industry and FDA (October 22, 2002)

Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA (December 13, 2002)

Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA (December 19, 2002; Final Issued on June 3, 2003)

Chemical Indicators Premarket Notification 510(k) Submissions; Draft Guidance for Industry and FDA (January 27, 2003)

Surgical Masks - Premarket Notification 510(k) Submissions; Draft Guidance for Industry and FDA (May 15, 2003)

- OIVD Draft Guidance Documents for Comment Purposes Only

Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns; Draft Guidance for Industry and FDA Reviewers (February 27, 2003)