| Announcement
of a Joint Meeting of the Ear, Nose and Throat Devices Panel and the
Dental Products Panel of the Medical Devices Advisory Committee - October
6, 2004 |
July 30, 2004
|
| Agenda,
Briefing, Roster, and Questions for the July 28-29, 2004 Circulatory
System Devices Panel Meeting |
July 28, 2004
|
| Consumer
Information on: Euclid Systems Orthokeratology (oprifocon A) Contact
Lenses for Overnight Wear |
July 27, 2004
|
| PMA
Final Decisions for June 2004 |
July 22, 2004
|
| Class
1 Medical Device Recall - Roche Molecular Systems COBAS TaqMan and TaqMan
48 Analyzers |
July 22, 2004
|
| Class
1 Medical Device Recall - Boston Scientific Express2TM (bare metal)
Coronary Stent |
July 22, 2004
|
| Summary
Information for: R2 Technology, Inc. ImageChecker(r) CT CAD Software
System - Model LN-1000 - P030012 |
July 22, 2004
|
| Surgical
Stapler Information |
July 21, 2004
|
| Presentation:
Medical Device User Fee and Modernization act of 2002 (MDUFMA) - Quarterly
Update - July 15, 2004 |
July 21, 2004
|
| Daniel
G. Schultz, M.D., Named Director of FDA's Center for Devices and
Radiological Health |
July 20, 2004
|
| Class
1 Medical Device Recall - Ortho-Clinical Diagnostics VITROS Troponin I
Reagent Pack |
July 19, 2004
|
| OIVD
News: FDA Grants CLIA waiver for the Use of Oral Fluid Specimens with the
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test |
July 19, 2004
|
| Announcement
of Upcoming Meeting of the Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee - August 31, 2004 |
July 16, 2004
|
| Summary
Information on: Restylane(tm) Injectable Gel - P020023 |
July 16, 2004
|
| Summary
Information on: Alcon Laboratories, Inc. LADARVision(r) 4000 Excimer Laser
System - P970043/S015 |
July 16, 2004
|
| Summary
Information on: St. Jude Medical(r) Epic(tm) HF System including the
Epic(tm) HF Model V-338 Cardiac Resynchronization Therapy Defibrillator,
the Aescula(tm) LV Model 1055K Lead, the QuickSite(tm) LV Model 1056K
Lead, and the Model 3307 v4.5m Programmer Software - P030054 |
July 16, 2004
|
| Summary
Information for: Stelid II steroid eluting pacing leads - Models BTF25D,
BTF26D, BJF24D, BJF25D, UTF25D, and UTF26D Stelix steroid eluting pacing
leads models BR45D and BR46D Stelix II steroid eluting pacing leads model
BRF25D and BRF26D - P020030 |
July 16, 2004
|
| 2004
PDA/FDA Joint Regulatory Conference Information |
July 15, 2004
|
| Dental
Products Panel Meeting Summary - July 13, 2004 |
July 15, 2004
|
| FDA
Talk Paper - FDA Approves Software System to Help Detect Lung Nodules |
July 12, 2004
|
| Class
1 Medical Device Recall - Carl Zeiss Meditec Ophthalmic System |
July 9, 2004
|
| Consumer
Information on: St. Jude Medical(r) Epic(tm) HF and Atlas(r) + HF Dual
Chamber Implantable Cardioverter Defibrillator Systems with Cardiac
Resynchronization Therapy |
July 9, 2004
|
| Class
1 Medical Device Recall - Boston Scientific Taxus Coronary Stent |
July 9, 2004
|
| Class
1 Medical Device Recall - Arjo Alenti Lift Hygiene Chair |
July 9, 2004
|
| Fifth
Annual Report of the Medical Devices Annex to the U.S./EC Mutual
Recognition Agreement (2003) |
July 8, 2004
|
| FDA
Clears Robotic-Like Device for Heart Surgery |
July 7, 2004
|
| 510(k)
Final Decisions Rendered for June 2004 |
July 6, 2004
|
| Special
Note: The 2nd Annual Stakeholder Meeting on the Implementation of the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) will be
held on Thursday, November 18, 2004 |
July 6, 2004
|
| 2004
FDA Workshop on Pre-Clinical Testing for Endovascular Grafts |
July 5, 2004
|
|
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