| Agenda,
Briefing Material, Panel Roster and Participant Roster available for the
Ophthalmic Devices Panel - August 1, 2002 |
July
31, 2002 |
| Consumer
Information on: Indermil Tissue Adhesive |
July
31, 2002 |
Transcript
for General and Plastic Surgery Devices Panel
July
8 , 2002 | July
9, 2002 |
July
29, 2002 |
| Transcript
Correction for Technical Electronic Product Radiation Safety Standards Committee
- May 22, 2002 |
July
29, 2002 |
| Summary
for Obstetrics and Gynecology Devices Panel Meeting -- July 22 and 23, 2002 |
July
29, 2002 |
| Frequently
Asked Questions on the Recognition of Consensus Standards; Guidance for
Industry and for (pdf file) |
July
29, 2002 |
| View
All Patient Safety News Broadcasts on Web |
July
26, 2002 |
| Summary
of General and Plastic Surgery Devices Panel - July 8 and 9, 2002 |
July
25, 2002 |
| FDA
Public Health Web Notification: Cochlear Implant Recipients may be at Greater
Risk for Meningitis |
July
24, 2002 |
| Agenda,
Questions, Roster and Briefing Material for the Obstetrics and Gynecology
Devices Panel Meeting |
July
19, 2002 |
| FDA
Approves New Indication for Implantable Cardioverter Defibrillators |
July
19, 2002 |
| Class
II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry
and FDA (PDF file) |
July
17, 2002 |
| Class
II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone
Cement; Guidance for Industry and FDA (PDF file) |
July
17, 2002 |
| FDA
Announces the Destruction of Unsafe Medical Devices |
July
17, 2002 |
| Medical
Devices; Apnea Monitor; Special Controls |
July
17, 2002
|
| Draft
Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy
and Dental Mercury Labeling; Availability |
July
17, 2002
|
| Related
Document: Special Control Guidance Document on Encapsulated Amalgam, Amalgam
Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA |
July
17, 2002
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
July
17, 2002
|
| Medical
Devices; Reclassification of Polymethylmethacrylate (PMMA) Bone Cement |
July
17, 2002
|
| Related
Document: Class II Special Controls Guidance Document: Polymethylmethacrylate
(PMMA) Bone Cement; Guidance for Industry and FDA (PDF file) |
July
17, 2002
|
| July-August
2002 FDA Consumer Magazine |
July
16, 2002 |
| Patient
Safety News for July now available |
July
16, 2002 |
| PMA
Final Decisions Rendered for June 2002 |
July
15, 2002 |
| MQSA
- 2000 Report to Congress on the Performance of Accreditation Bodies
- Executive
Summary - Approved
Alternative Requirements (Updated to Include #5, #6 and #7) |
July
12, 2002 |
| Consumer
Information on: Roche Diagnostics Accu-Check Advantage Module |
July
12, 2002 |
| Consumer
Information on: TheraSense Inc. FreeStyle Tracker Diabetes Management System |
July
12, 2002 |
| Consumer
Information on: NNMT Medical Inc. CardioSEAL Septal Occlusion System with
QwikLoad |
July
12, 2002 |
| FDA
Public Health Notification: PVC Devices Containing the Plasticizer DEHP |
July
12, 2002 |
| PMA
Final Decisions Rendered for June 2002 |
July
12, 2002 |
| Summary
Information for: InFUSE(tm)Bone Graft/LT-CAGE(tm) Lumbar Tapered Fusion
Devices |
July
11, 2002 |
| Consumer
Information on: MED-EL COMBI 40+ Cochlear Implant System |
July
11, 2002 |
| MAUDE
Database Files - Now Updated |
July
11, 2002 |
| Frequently-Asked-Questions
about the Reprocessing and Reuse of Single-Use Devices by Third-Party and
Hospital Reprocessors: Three Additional Questions; Final Guidance for Industry
and FDA Staff |
July
11, 2002 |
| Office
of Science and Technology FY2001 Annual Report |
July
11, 2002 |
| Announcement:
Reuse CD-ROM Available to Hospitals |
July
10, 2002 |
Class 1 Medical
Device Recall:
EGG
Monitor | Band
Ligature | Infant
Bassinet |
July
10, 2002 |
| FDA will hold
a public meeting on Friday, July 26, 2002, to solicit comments for the development
of a regulation on bar code labeling for human drug products including biologics
AND to explore issues regarding bar code labeling for medical devices. For
more details and to register |
|
Briefing
Information for the General and Plastic Surgery Devices Panel Meeting
July
8 | July
9 |
July
8, 2002 |
| 510(k)Decisions
Rendered for June 2002 |
July 5, 2002
|
| Announcement
of Upcoming Meeting of the Dental Products Panel Advisory Committee - August
22, 2002 |
July
2, 2002 |
| Summary
Information for Technolas 217A Excimer Laser System |
July
2, 2002 |
| Summary
Information for Ancure Aortoiliac System |
July
2, 2002 |
| Cardiac
Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for
Industry |
July
1, 2002 |
| Public
Meeting on Bar Code Labeling for Medical Products - July 26, 2002 |
July
1, 2002 |
|
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