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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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51 to 60 of 61 Results
productcode NIQ PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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Device
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PMA
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Resolute Onyx Coronary Stent System MEDTRONIC VASCULAR P160043 S011 03/15/2018
XIENCE V/nano Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR INC. P070015 S139 03/05/2018
XIENCE Prime/Xpedition/Alpine/Sierra Everolimus El... ABBOTT VASCULAR P110019 S096 03/05/2018
Promus Element Plus Everolimus-Eluting Platinum Ch... Boston Scientific Corp. P110010 S153 02/23/2018
Synergy Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S037 02/23/2018
XIENCE V Everolimus Eluting Coronary Stent System ABBOTT VASCULAR INC. P070015 S140 02/21/2018
XIENCE PRIME/SV/LL and XIENCE/SV/LL and XIENCE Alp... ABBOTT VASCULAR P110019 S097 02/21/2018
PROMUS Element Plus Everolimus-Eiuting Stent Syste... Boston Scientific Corp. P110010 S152 02/16/2018
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S001 02/08/2018
XIENCE V Everolimus Eluting Coronary Stent System ... ABBOTT VASCULAR INC. P070015 S138 01/25/2018
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