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 Tue, 09 Feb 2010 10:24:45 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/ Fri, 05 Feb 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm199999.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Fri, 05 Feb 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-2458.htm This document provides guidance on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods. Fri, 05 Feb 2010 05:00:00 GMT Reason for Recall: The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. Thu, 04 Feb 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm199918.htm The purpose of this document is to inform you that FDA is extending to 18 months from the date of this notice the total recommended time period for transitioning from Steris Corporation?s modified System 1 processor (SS1) to legally-marketed alternative.. Tue, 02 Feb 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm199567.htm The purpose of the public workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various neurological and neurocognitive assessments for pediatric patients implanted with... Tue, 02 Feb 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-2110.htm The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. Fri, 29 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199258.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for Medtronic Melody® Transcatheter Pulmonary Valve (Model PB10) and Medtronic Ensemble® Transcatheter Valve Delivery System (NU10) (H080002). Fri, 29 Jan 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=H080002 The device separates the red blood cells from plasma to determine the patient?s hematocrit. A low hematocrit reading is a possible indicator of anemia. Thu, 28 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm199186.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for ProGEL? Pleural Air Leak Sealant (P010047). Wed, 27 Jan 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P010047 The ProGEL? Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure.. Wed, 27 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199028.htm The purpose of the public meeting is to identify actions that CDRH can consider taking to strengthen the premarket notification process for review of medical devices, also known as the 510(k) process. FDA is seeking input on a number of identified... Wed, 27 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-1620.htm On March 12, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. Wed, 27 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-1519.htm FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Tue, 26 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-1438.htm Reason for Recall: Inspections conducted in October 2009 of the company's facilities found that their needles "cored" in 60 to 72 percent of tests. These cores can cause the ports to leak and they can also potentially enter a patient's body when... Tue, 26 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm198790.htm FDA today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint Securetouch+ Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation. Tue, 26 Jan 2010 05:00:00 GMT http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198676.htm These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for December 2009. Mon, 25 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm198613.htm The guidance is intended to provide recommendations for the preparation of investigational device exemption (IDE) and premarket approval (PMA) applications for replacement heart valves that are not allograft heart valves or more than minimally... Wed, 20 Jan 2010 05:00:00 GMT This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time. Wed, 20 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-990.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-795.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-792.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-791.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-794.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-796.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-793.htm FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Tue, 19 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-790.htm The FDA is announcing a public meeting entitled: Clinical Accuracy Requirements for Point of Care Blood Glucose Meters. The purpose of the public meeting is to discuss the clinical accuracy requirements of blood glucose meters and other topics related... Fri, 15 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-742.htm The amendment is being made to reflect a change in the Contact Person and Procedure portions of the document, and to provide notice of the availability of a docket for public comment. There are no other changes. Mon, 11 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-172.htm On March 5, 2010, the committee will discuss and make recommendations regarding clinical risks and benefits of post-market actions in response to insulin pump failures. Mon, 11 Jan 2010 05:00:00 GMT http://edocket.access.gpo.gov/2010/2010-174.htm