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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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41 to 50 of 61 Results
productcode NIQ PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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PMA
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EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S002 04/17/2018
Xience V Everolimus Eluting Coronary Stent System,... ABBOTT VASCULAR INC. P070015 S142 04/16/2018
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S089 04/16/2018
Xience Prime, Xience Prime SV, Xience Prime LL, Xi... ABBOTT VASCULAR P110019 S100 04/16/2018
Resolute Onyx Zotarolimus-eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S014 04/16/2018
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S015 04/16/2018
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S003 04/05/2018
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S038 03/28/2018
SYNERGY Everolimus-Eluting Platinum Chronium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S032 03/23/2018
Resolute Integrity Coronary Stent Systems Medtronic Vascular P110013 S087 03/15/2018
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