| Summary
Information for DERMAGRAFT - P000036 |
October
31, 2001
|
| Consumer
Information on: Home Monitoring System with the BA03 DDDR Pulse Generator |
October
31, 2001
|
| Consumer
Information on: Microny SR+ Cardiac Pacemaker (Model 245T) |
October
30, 2001
|
| Open
Public Meeting Announcement: New FDA Guidance on Clinical Trial Data Monitoring
Committees - 11/27/01 |
October
30, 2001
|
| Blue
Book Memorandum D01-1: Procedures for Handling Inquiries Regarding the Need
for an Investigational Device Exemptions Application for Research Involving
Medical Devices |
October
29, 2001
|
| Summary
Information on LaserSight LaserScan LSX Excimer Laser System - P980008/S005 |
October
26, 2001
|
| Consumer
Information on: Model 3100B High-Frequency Oscillatory Ventilator - P890057/S014 |
October
26, 2001
|
| Proceedings
of the ACR/FDA Workshop on Fluoroscopy - October 16, 1992 |
October
24, 2001
|
| Briefing
Information for the 10/29/01 Clinical Chemistry and Clinical Toxicology
Devices Panel Meeting - 10/29/01 |
October
23, 2001
|
| MAUDE
Database - Now Updated through 9/28/01 |
October
23, 2001
|
| Summary
Information for PROSTALAC Hip Temporary Prosthesis - H000004 |
October
23, 2001
|
| Summary
Information for OP-1 Implant - H010002 |
October
23, 2001
|
| Summary
from the October 11-12, 2001 Microbiology Devices Panel Meeting |
October
22, 2001
|
| Notice
of Upcoming Tissue Engineered Medical Products Teleconference - 11/8/01 |
October
22, 2001
|
Summary
Information for Focus Night and Day (lotrafilcon A) Soft Contact Lens
P010019
| P000030 |
October
19, 2001
|
| Summary
Information for Optical Biopsy System - P990050 |
October
19, 2001
|
| MQSA
- Warning Letters: Roadmap to Corrective Action |
October
17, 2001
|
| FDA
Approves 30-Night Continuous Wear Contact Lenses |
October
12, 2001
|
| FDA
Approves New Type of Pacemaker |
October
11, 2001
|
Microbiology
Devices Panel Meeting Information for 10/12/01
Draft
agenda | Attendees
| Draft
questions for panel (PDF) | Briefing
information |
October
11, 2001
|
| Summary
Information on: Stinger Ablation Catheter and TempLink Extension Cable-
P000020 |
October
11, 2001
|
| Summary
Information on: INTEGRITY AFx DR Model 5346 - P880086/S083 (Generator) &
P830045/S076 (Programmer) |
October
11, 2001
|
| List
of Over-the-Counter In Vitro Diagnostic Devices - Updated |
October
11, 2001
|
| Consumer
Information on: Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator
System |
October
11, 2001
|
| Consumer
Information on: Mosaic Porcine Bioprosthesis, Model 305 (Aortic) and Model
310 (Mitral) |
October
11, 2001
|
Microbiology
Devices Panel - 10/11/01 Meeting
Draft Agenda | Attendees
| Draft
questions for Endotoxin Activity Assay 3 (PDF) | Draft
questions for panel (PDF) | Briefing
Information |
October
10, 2001
|
Summary
Information on DiaSorin Plus Assays
P990042
| P990041
| P990038
| P990045
| P990043
| P990044 |
October
9, 2001
|
| Premarket
Approval Decisions Rendered for September 2001 |
October
5, 2001
|
| Strategic
Planning - Taking Us Into the Future - September 2001 |
October
5, 2001
|
| Consumer
Information on: DERMAGRAFT |
October
5, 2001
|
| 510(k)Decisions
Rendered for September 2001 |
October
5, 2001
|
| Letter
to Hospitals Re: Changes in Enforcement of FDA's Requirements on Reprocessing
of Single-Use Devices |
October
5, 2001
|
| Consumer
Information on: Deflux Injectable Gel |
October
3, 2001
|
| Consumer
Information on: Elecsys HBsAg Immunoassay, Elecsys HBsAg Confirmatory, and
PreciControl HBsAg |
October
3, 2001
|
| Consumer
Information on: Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator
System |
October
3, 2001
|
| Summary
Information on Deflux Injectable Gel - P000029 |
October
1, 2001
|
| LASIK
Updates for October 2001 |
October
1, 2001
|
| Notice
of Upcoming Meeting of the Ophthalmic Devices Panel on November 30, 2001 |
October
1, 2001
|
|
|
