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July/August 2001 Archive

Summary Information for: Medtronic InSync Biventricular Pacing System including the InSync Model 8040 Pulse Generator, Attain LV Model 2187 and Attain CS Model 2188 Leads - P010015
August 30, 2001
Announcement of Upcoming Meeting of the Microbiology Devices Panel - October 11-12, 2001
August 30, 2001
Summary Information for GlucoWatch Automatic Glucose Biographer - P990026
August 29, 2001
Consumer Information on: Integrity AFx DR Model 5346 Generator/Programmer - P880086S083 / P830045S076
August 29, 2001
FDA Approves First Pacemaker For Congestive Heart Failure
August 28, 2001
Consumer Information on: Medtronic InSync Biventricular Pacing System including the InSync Model 8040 Pulse Generator, Attain LV Model 2187 and Attain CS Model 2188 Leads - P010015
August 28, 2001
Consumer Information on: AquaFlow Collagen Glaucoma Draining Device - Model CGDD-20 - P000026
August 27, 2001
CDRH Organization Chart - Updated
August 27, 2001
Gastroenterology-Urology Devices Panel Meeting Summary, August 17, 2001
August 24, 2001
Consumer Information on: UBIS 5000 Ultrasound Bone Sonometer - P000055
August 24, 2001
Consumer Information on: Carisolv Non-Invasive Caries Removal System - P000005
August 24, 2001
Summary for UBIS 5000 - P000055
August 23 , 2001
Consumer Information on: Given Diagnostic Imaging System - K010312
August 21 , 2001
FDA Actions on Reprocessed Single Use Devices
August 17 , 2001
Notice of Upcoming Circulatory System Devices Panel Meeting - September 10-11, 2001
August 16 , 2001
Briefing Material for the August 17, 2001 Gastroenterology and Urology Devices Panel Meeting
August 16 , 2001
Notice of Upcoming Clinical Chemistry and Clinical Toxicology Device Panel Meeting - September 24, 2001
August 14 , 2001
When Facilities No Longer Perform Mammography: Ensuring Patients' Access to Medical Record
August 14 , 2001
Summary for Carisolv Non-Inavsive Dental Caries Removal System - P000005
August 13 , 2001
Summary for SUPARTZ Dispo - P980044
August 13 , 2001
Premarket Approval Decisions Rendered for July 2001
August 13 , 2001
CLIA - List of Tests Waived by FDA - Updated
August 10, 2001
CLIA - List of Analytes Currently on the Waived List- Updated
August 10, 2001
Questions for the August 22, 2001 National Mammography Quality Assurance Advisory Committee
August 10, 2001
510(k) Decisions Rendered for July 2001
August 10, 2001
Clinical Laboratory Improvement Amendments (CLIA) Database Now Available
August 8, 2001
Briefing Information for Day 1 of the Orthopedic and Rehabilitation Devices Panel Meeting - August 8-9, 2001
August 7, 2001

Presentation: FDA and the Reuse of Single Use Devices: What this Reveals about the FDA Regulation of Devices

August 7, 2001
Announcement of the Upcoming Meeting of the Medical Devices Dispute Resolution Panel - September 6, 2001
August 3, 2001
FDA Clears Camera Pill to Photograph Small Intestine
August 2, 2001
Note to Medical Physicists in Ohio
August 2, 2001
Consumer Information on: Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit - P000044
August 2, 2001
Summary for Corometrics 120-F Series Material/Fetal Monitor with Intetrated Fetal Oxygen Saturation Monitoring - P000016
August 2, 2001
LASIK Eye Surgery - July 2001 Updates
August 1, 2001
Consumer Information on RapidScreen RS-2000 - P000041
July 31, 2001
Presentation: Reprocessing of Single-Use Devices (SUDs) by Hospitals and Third-Parties
July 31, 2001
Workshop on Pre-Clinical Testing for Endovascular Grafts Now Available
July 27, 2001
Revised Summary of Safety and Effectiveness (SSE) for TMJ Fossa Eminence Prosthesis-P000035 - Now Available
July 25, 2001
CDRH National Center Liaison Representative Roster- Updated
July 25, 2001