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July 2005 Archive

Class I Medical Device Recall: Guidant Corp. Pacemakers July 27, 2005
Brief Summary for the 07/15/05 Meeting of the Immunology Devices Panel July 26, 2005
Summary for St. Jude Medical Frontier(tm) Model 5508L and Frontier(tm) II Model 5586 Cardiac Resynchronization Therapy Pacemakers (CRT-P) supported on the Model 3510 programmer platforms with the Model 3307, v4.8m programmer software P030035/S003 July 26, 2005
Class I Medical Device Recalls: Baxter Healthcare Corp. COLLEAGUE(r) Volumetric Infusion Pumps July 22, 2005
FDA Announces Guidant's Class I Pacemaker Recall July 22, 2005
FDA Announces Class I Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps July 21, 2005
Breast Cancer Information July 19, 2005
PMA Monthly Approval List - June 2005 July 19, 2005
Class I Medical Device Recalls: CONTAK RENEWAL and CONTAK RENEWAL 2 CRT-Ds July 18, 2005
Summary Information for: Onco-LIFE(tm) Endoscopic Light Source and Video Camera (Onco-LIFE(tm)) - P950042s003 July 18, 2005
Summary Information on: VNS Therapy System - P970003s050 July 18, 2005
Class I Medical Device Recalls: Ventak PRIZM 2 DR ICDs July 18, 2005
Consumer Information on: VNS Therapy System July 18, 2005
Advice for Patients with VENTAK PRIZM(r) 2 DR and CONTAK RENEWAL(r) Implantable Cardioverter Defibrillators July 15, 2005
FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM(r) 2 DR and CONTAK RENEWAL(r) Implantable Cardioverter Defibrillators July 15, 2005
Briefing Information for the 07/15/05 Meeting of the Immunology Devices
Panel
July 14, 2005
Medical Device Safety: Updated July 8, 2005
New On-line Registration and Listing Forms, FDA 2891 and FDA 2892 July 7, 2005
510(k) Final Decisions - June 2005 July 5, 2005
Class I Medical Device Recalls: Vail Products, Inc. Enclosed Bed Systems July 1, 2005
Press Release: FDA Notifies Public that Vail Products, Inc., Issues Nationwide Recall July 1, 2005
FDA Updates Consumers on Guidant Corporation's Implantable Defibrillators July 1, 2005
Obstetrics and Gynecology Devices Panel Meeting Brief Summary for June 23, 2005 July 1, 2005
Summary Information for: ADVIA Centaur(r) HBsAg ReadyPack Reagents, ADVIA Centaur(r) HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur(r) HBsAg Quality Control Material - P030049 July 1, 2005