Items added to the FDA's Center for Devices and Radiological Health website within the last month. http://www.fda.gov/cdrh/newpg.html en-us Thu, 02 Jul 2009 10:51:08 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/ The Center for Devices and Radiological Health (CDRH) will be relocating to the FDA White Oak campus located at 10903 New Hampshire Avenue, Silver Spring, MD 20993 this summer. Wed, 01 Jul 2009 04:00:00 GMT http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ucm142391.htm The CDRH Forum is established for the exchange of medical device regulatory information between the USFDA CDRH and its counterpart agencies in other countries. The training is limited to international medical device regulatory authorities. Tue, 30 Jun 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm169899.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for Cervista™ HPV 16/18 (P080015). Tue, 30 Jun 2009 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080015 Labeling, Approval Order, and Summary of Safety and Effectiveness for CervistaTM HPV HR and GenfindTM DNA Extraction Kit (P080014). Tue, 30 Jun 2009 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080014 The TAXUS® Liberté® Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. Mon, 29 Jun 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm169592.htm PMA Final Decisions for May 2009 Mon, 15 Jun 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm166550.htm Reason for Recall: The Kappa and Sigma pacemakers in these identified series may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Fri, 12 Jun 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm166344.htm The FDA is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Thu, 11 Jun 2009 04:00:00 GMT http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm The Panel met to discuss and provide recommendations regarding general issues related to the use of ultrafiltration devices in the treatment of extracellular fluid overload with a focus in patients experiencing heart failure. Specifically... Thu, 11 Jun 2009 04:00:00 GMT http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/ucm165950.htm The committee will discuss and make recommendations on a CLIA Waiver application for the HemoCue WBC Analyzer, sponsored by HemoCue, Inc. Tue, 09 Jun 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-13373.htm Mon, 08 Jun 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm164648.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for TAXUS® Liberté® Atom? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) (P060008S008). Wed, 03 Jun 2009 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P060008S008