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Evaluation of Automatic Class III Designation (De Novo) Classification Order (DEN140032 added)
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Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
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Emergency Use Authorizations: RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics)
OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with whole Blood – July 31, 2015 On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa…
Summary Information for: Fluency® Plus Endovascular Stent Graft
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3D Printing of Medical Devices
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Summary Information for: ImageReady MR Conditional Pacing System and Ingevity Pace/Sense Lead
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Summary Information for: Impella Ventricular Support Systems
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Transcript posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting
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