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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
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Decision
Date
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enlite glucose sensors MEDTRONIC Inc. P120010S072 01/21/2016
radiesse injectable implant MERZ NORTH AMERICA, INC P050052S081 01/20/2016
artegraft collagen vascular graft LeMaitre Vascular, Inc. N16837S021 01/19/2016
amplatzer septal occluder Abbott Medical P000039S051 01/08/2016
acrysof iq restore +3.0d add power intraocular lens Alcon Research, Ltd. P040020S058 01/06/2016
cordis precise nitinol stent systems Cordis US Corporation P030047S030 01/04/2016
freezor cardiac cryoablation catheter, freezor xtra surgical catheter Medtronic CryoCath LP P020045S069 12/31/2015
birmingham hip resurfacing (bhr) system Smith & Nephew, Inc. P040033S024 12/11/2015
superion interspinous spacer system Boston Scientific Neuromodulation P140004S003 12/11/2015
acrysof toric posterior chanber iol, acrysof toric single-piece natural iol, acrysof iq toric iol & acrysof toric iol ALCON LABORATORIES, INC. P930014S085 12/04/2015

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