| Mammography
Policy Guidance Help System - Updated |
October 31, 2003
|
| MQSA
Program Accomplishments, June 1993 through September 2003 |
October 31, 2003
|
| FDA
Public Health Web Notification: Information for Physicians on Sub-acute
Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis
CYPHER(tm) Coronary Stent |
October 29, 2003
|
| FDA
Talk Paper: FDA Advises Physicians of Adverse Events Associated with
Cordis Cypher Coronary Stents |
October 29, 2003
|
| Summary
Information for: WaveLight ALLEGRETTO WAVE(tm) Excimer Laser System -
P020050 |
October 28, 2003
|
| Summary
Information for: Medtronic Vascular Driver(tm) Over-the-Wire, Rapid
Exchange, and Multi-Exchange Coronary Stent Systems- P030009 |
October 28, 2003
|
| Summary
Information for: FemCap(tm) - P020041 |
October 28, 2003
|
| Summary
Information for: Medtronic AVE Bridge(tm) Extra Support Over-The-Wire (OTW)
Renal Stent System - P020007 |
October 28, 2003
|
| Summary
Information for: WaveLight ALLEGRETTO WAVE(tm) Excimer Laser System -
P030008 |
October 28, 2003
|
| Transcript
from the 10/1/03 Technical Electronic Product Radiation Safety Standards
Committee Meeting |
October 27, 2003
|
| Third
Party Inspections and the Accredited Persons Inspection Program |
October 24, 2003
|
| Brief
Summary from the General and Plastic Surgery Devices Panel Meeting -
October 14 and 15, 2003 |
October 21, 2003
|
| Patient
Safety Portal - Updated for October 2003 |
October 17, 2003
|
| Safety
Tip: Patient-Controlled Analgesia (PCA) Pumps with Keypad Locking
Mechanisms |
October 17, 2003
|
| Transcript
from the 10/2/03 Circulatory System Devices Panel Meeting |
October 17, 2003
|
| Transcript
from the 10/3/03 Ophthalmic Devices Panel Meeting |
October 17, 2003
|
| Letter
to Manufacturers and Assemblers of Diagnostic X-ray Components and Systems
re: Manufacturers' Information Disclosure Obligations under Title
21CFR1020.30(g) |
October 16, 2003
|
| ContactListing
for Breast Implant Information |
October 14, 2003
|
| Misys
Healthcare Systems Issues Nationwide Recall of B-AUT-RAPID-LAB Software |
October 14, 2003
|
| FDA
& You, Issue No. 1, Fall 2003 |
October 10, 2003
|
| MAUDE
Zip Data Files - Updated Through September 2003 |
October 10, 2003
|
| Consumer
Information on: WaveLight ALLEGRETTO WAVE(tm) Excimer Laser System |
October 10, 2003
|
| Agenda,
Roster, Briefing Material and Slides for the October 14-15, 2003 General
and Plastic Surgery Devices Panel Meeting |
October 10, 2003
|
| Consumer
Information on: S.M.A.R.T.(tm) Nitinol Stent System and S.M.A.R.T.(tm)
Control(tm) Nitinol Stent |
October 10, 2003
|
| PMA
Final Decisions for September 2003 |
October 10, 2003
|
| FDA
Warns Consumers Not to Use Decorative Contact Lenses Without Proper
Professional Involvement |
October 10, 2003
|
| Class
I Recalls: CoaguChek PT Test Strips |
October 8, 2003
|
| Notice
of Upcoming Meeting of the Circulatory System Devices Panel - November 20,
2003 |
October 8, 2003
|
| Brief
Summary from the Ophthalmic Devices Panel Meeting - October 3, 2003 |
October 7, 2003
|
| Brief
Summary from the Circulatory System Devices Panel Meeting - October 2,
2003 |
October 6, 2003
|
| 510(k)
Final Decisions Rendered for September 2003 |
October 6, 2003
|
| Information
on the Upcoming General and Plastic Surgery Devices Panel Meeting -
November 21, 2003 |
October 6, 2003
|
| Panel
Roster for the October 14 and 15, 2003 General and Plastic Surgery Devices
Panel Meeting |
October 3, 2003
|
| Agenda,
Roster, Questions and Briefing Information for the October 3, 2003
Ophthalmic Devices Panel Meeting |
October 2, 2003
|
| Agenda,
Roster, Questions and Briefing Information for the October 2, 2003
Circulatory System Devices Panel Meeting |
October 2, 2003
|
| FDA
Patient Safety News - October Broadcast |
October 1, 2003
|
|
|
