| Notice
of Upcoming Meeting of the Circulatory System Devices Panel - October 2,
2003 |
August 29, 2003
|
| Consumer
Information - ThinPrep(tm) Imaging System |
August 29, 2003
|
| Brochure
- Home Healthcare Medical Devices: A Checklist |
August 28, 2003
|
| Notice
of Upcoming Meeting of the Technical Electronic Product Radiation Safety
Standards Committee - October 1, 2003 |
August 28, 2003
|
| Explanation
of New Goal for Reducing Device Approval Times |
August 27, 2003
|
| Summary
Information for INDEPENDENCE(tm) iBOT(tm) 3000 Mobility System - P020033 |
August 26, 2003
|
| Summary
Information for Response(tm) CV Catheter System - P020052 |
August 26, 2003
|
| Summary
Information for S.M.A.R.T.(tm) Nitinol Stent System and S.M.A.R.T.(tm)
Control Nitinol Stent System- P020036 |
August 26, 2003
|
| Notice
of Upcoming General and Plastic Surgery Devices Panel Meeting - October
14-15, 2003 |
August 26, 2003
|
| Notice
of Upcoming Ophthalmic Devices Panel Meeting - October 3, 2003 |
August 21, 2003
|
| Class
1 Medical Device Recall: ProbeTec(tm) ET Instrument |
August 21, 2003
|
| Brief
Summary From the Neurological Devices Panel Meeting - August 5, 2003 |
August 19, 2003
|
| PMA
Final Decisions for July 2003 |
August 15, 2003
|
| FDA
Approves Stair-Climbing Wheelchair |
August 15, 2003
|
| Summary
Information for Ceramic TRANSCEND(r) Hip Articulation System - P030027 |
August 12, 2003
|
| Consumer
Information on: Response(tm) CV Catheter System - P020052 |
August 12, 2003
|
| Consumer
Information on: 7F Freezor(r) Cardiac Cryoablation Catheter and CCT.2
CryoConsole System - P020045 |
August 12, 2003
|
| Consumer
Information on: Zenith(r) AAA Endovascular Graft - P020018 |
August 12, 2003
|
| Medical
Device Reprocessor Signs Consent Decree - Agrees to Correct Manufacturing
Problems |
August 7, 2003
|
| Summary
Information for ProCol(r) Vascular Bioprosthesis - P020049 |
August 7, 2003
|
| FDA
Announces New Goal for Reducing Total Device Review Times |
August 6, 2003
|
| 510(k)s
Final Decisions Rendered for July 2003 |
August 5, 2003
|
| Presentations
and Transcript from the July 8, 2003 Innovative Systems for Delivery of
Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges;
Public Workshop |
August 5, 2003
|
| Presentations
and Transcript from the July 14, 2003 Public Meeting: SARS Diagnostics:
Scientific and Regulatory Challenges |
August 5, 2003
|
| Patients
Safety Portal - Updated |
August 4, 2003
|
| Agenda,
Questions, Roster and Briefing Material for the 8/5/03 Neurological
Devices Panel Meeting |
August 4, 2003
|
| Mammography
- National Statistics Updated for August 2003 |
August 4, 2003
|
| Mammography
- Digital Accreditation Information- Updated |
August 4, 2003
|
| Medical
Device User Fee and Modernization Act of 2002 - "FAQs" - Updated |
August 4, 2003
|
| Actions
and Reports with a Due Date Specified by the Medical Device User Fee and
Modernization Act of 2002 or by Regulations and Notices Issued to
Implement MDUFMA - Updated |
August 4, 2003
|
|
|