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Recent Additions In CDRH

November 5, 2004
	510(k)s Final Decisions Rendered for October 2004
November 4, 2004
	Federal Register: Medical Devices; Revision of the Identification of the Iontophoresis Device; Withdrawal.
	Federal Register: Medical Devices; Reclassification of the Iontophoresis Device.
November 3, 2004
	Consumer Information on: ExAblate® 2000 System
	FDA Completes Review of Reprocessed Single Use Devices
	Consumer Information on : Syncardia Temporary CardioWest Total Artificial Heart (TAH-t)
October 29, 2004
	FDA Warns of Dangers of Decorative Contact Lenses
	Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
October 28, 2004
	Consumer Information on: ADVIA Centaur® Anti-HBs ReadyPack Reagents and Calibrators
	Consumer Information on: ADVIA Centaur® HBc IgM ReadyPack Reagents, ADVIA Centaur® HBc IgM Quality Control (Calibrator and Control) Materials
	Consumer Information on: Verisyse™ Phakic IOL
October 27, 2004
	Medical Device Recall: Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills
	Presentation: MDUFMA Quarterly Update - 10/20/04
	FDA Approves Artificial Disc to Treat Back Pain
	Summary Information for: Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) - P030011
	Summary Information for: Hylaform Plus - P030032/S001
October 22, 2004
	FDA Approves New Device to Treat Uterine Fibroids
October 19, 2004
	FDA Approves Temporary Artificial Heart
October 18, 2004
	FDA Public Health Web Notification: Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent
October 15, 2004
	Cochlear Implants Information
October 14, 2004
	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement.
	Federal Register: Stimulating Innovation in Medical Technologies, Public Meeting.
October 13, 2004
	Medical Device Recalls: Advanced Bionics Cochlear Auditory Implants
October 12, 2004
	Summary Information for: JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P040029
	Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Current Good Manufacturing Practices Quality System Regulation
	Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Information From U.S. Processors That Export to the European Community
	Federal Register: Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices
October 8, 2004
	Consumer Information on: Siemens Mammomat Novation DR Full Field Digital Mammography System
	PMA Final Decisions for September 2004
	Brief Summary from the Joint Meeting of the Dental Products and Ear, Nose and Throat Devices Panels - October 6, 2004
October 7, 2004
	Federal Register: Memorandum of Understanding Between the State of Illinois, Emergency Management Agency, Bureau of Radiation Safety and the Food and Drug Administration, Center for Devices and Radiological Health.
October 6, 2004
	Patient Safety Portal - Updated
	Federal Register: Memorandum of Understanding Between the State of Iowa, Department of Public Health, Bureau of Radiological Health and the Food and Drug Administration, Center for Devices and Radiological Health.
	Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications
October 5, 2004
	Consumer Information on: JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
	510(k)s Final Decisions Rendered for September 2004
October 4, 2004
	Federal Register: Guidance for Industry, Food and Drug Administration Staff, and Third Parties; Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria; Availability.
	Federal Register: Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 011.
	Federal Register: Orthopedic Devices; Effective Date of Requirement for Premarket Approval for Hip Joint Metal/Polymer or Ceramic/Polymer Semiconstrained Resurfacing Cemented Prosthesis.
October 1, 2004
	Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria - Guidance for Industry, FDA Staff, and Third Parties

Updated November 5, 2004

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