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Summary Information for: FENIX™ Continence Restoration System
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Summary Information for: Closer Vascular Sealing System (VSS)
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Class I Medical Device Recall: Dräger Evita V500 and Babylog VN500 Ventilators
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Presentations posted for February 18, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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24 Hour Summaries posted for February 25-26, 2016 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
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Workshop – 9th Annual Medical Device and Diagnostics Statistical Issues, Co-Sponsored by AdvaMed and FDA, May 3
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Consumer Information on: Cobas® HBV
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CDRH Research Programs
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Consumer Information on: Edwards SAPIEN XT Transcatheter Heart Valve
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Edwards SAPIEN XT Transcatheter Heart…