| Presentation:
Update 2003: FDA and CLIA (Given at IVD Roundtable 510(k) Workshop - April
22, 2003) |
April 30, 2003
|
| Announcement
of Mid-Year Stakeholder Meeting on the Implementation of MDUFMA Provisions
- June 6, 2003 |
April 29, 2003
|
| Presentation:
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) - April 21,
2003 |
April 28, 2003
|
| Summary
Information for TECHNOLAS(r) 217A Excimer Laser System - P990027/S004 |
April 28, 2003
|
| Summary
Information for Essure(tm) System - P020014 |
April 28, 2003
|
| Implementation
of the Inspection by Accredited Persons Program Under The Medical Device
User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance
for Industry, FDA Staff, and Third Parties |
April 25, 2003
|
| Summary
Information for: CYPHER(tm) Sirolimus-eluting Coronary Stent on RAPTOR(r)
Over-the-Wire Delivery System or RAPTORRAIL(r) Rapid Exchange Delivery
System - P020026 |
April 25, 2003
|
| FDA
Approves Drug-Eluting Stent for Clogged Heart Arteries |
April 25, 2003
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
April 25, 2003
|
| Guidance
for Industry and FDA; 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;
Availability. |
April 25, 2003
|
| Summary
Information for: CYPHER(tm) Sirolimus-eluting Coronary Stent on RAPTOR(r)
Over-the-Wire Delivery System or RAPTORRAIL(r) Rapid Exchange Delivery
System - P020026 |
April 24, 2003
|
| FDA
Approves Drug-Eluting Stent for Clogged Heart Arteries |
April 24, 2003
|
| FDA
Grants Expanded Use of Brain Implant for Movement Disorder |
April 17, 2003
|
| New
Humanitarian Device Exemption - Medtronic Activa Dystonia Therapy -
H020007 |
April 17, 2003
|
| FDA
Grants Expanded Use of Brain Implant for Movement Disorder |
April 16, 2003
|
| New
Humanitarian Device Exemption - Medtronic Activa Dystonia Therapy -
H020007 |
April 16, 2003
|
| Summary
from the April 10, 2003 Circulatory System Devices Panel Meeting |
April 15, 2003
|
| CDRH
Petitions |
April 10, 2003
|
| Recent
Presentations Given by the Office of In Vitro Diagnostic Device Evaluation
and Safety (OIVD) |
April 10, 2003
|
| Announcement
of Upcoming Meeting of the Dental Products Panel Advisory Committee - May
22, 2003 |
April 9, 2003
|
| Announcement
of Upcoming Meeting of the Circulatory System Devices Panel Advisory
Committee - May 29, 2003 |
April 9, 2003
|
| CDRH
International Standards Liaison Roster - Updated |
April 9, 2003
|
| CDRH
National Standards Liaison Roster - Updated |
April 9, 2003
|
| Agenda,
Roster, Questions, Briefing Information and Slides for the 4/10/03
Circulatory System Devices Panel Meeting |
April 9, 2003
|
| 510(k)s
Final Decisions Rendered for March 2003 |
April 7, 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 - #G03-1 |
April 4, 2003
|
| Laboratory
Safety Tip: Performance and Cautions in Using Rapid Influenza Virus
Diagnostic Tests |
April 3, 2003
|
| Announcement
of Upcoming Ophthalmic Devices Panel Meeting - May 23, 2003 |
April 2, 2003
|
| FDA
Patient Safety News - April Edition - Now Available |
April 2, 2003
|
| FDA
Approves Expanded Use of HPV Test |
April 2, 2003
|
| FDA
Public Health Web Notification: Complications Related to the Use of Bone
Cement in Treating Compression Fractures of the Spine |
April 2, 2003
|
| Announcement
of Upcoming Ophthalmic Devices Panel Meeting - May 23, 2003 |
April 1, 2003
|
| FDA
Patient Safety News - April Edition - Now Available |
April 1, 2003
|
| FDA
Approves Expanded Use of HPV Test |
April 1, 2003
|
| FDA
Public Health Web Notification: Complications Related to the Use of Bone
Cement in Treating Compression Fractures of the Spine |
April 1, 2003
|
| Now
Available: Minutes from the 01/17/03 Meeting of the Gastroenterology and
Urology Devices Panel |
April 1, 2003
|
| Now
Available: Minutes from the 11/20-21/02 Meeting of the Orthopaedics and
Rehabilitation Devices Panel |
April 1, 2003
|
| Now
Available: minutes from the 12/10/02 Meeting of the Radiological Devices
Panel |
April 1, 2003
|
|
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