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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 63 Results
productcode NIQ PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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XIENCE V Everolimus Eluting Coronary Stent System ABBOTT VASCULAR INC. P070015 S148 03/24/2021
XIENCE Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S117 07/30/2021
XIENCE Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S113 05/13/2021
XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting C... ABBOTT VASCULAR P110019 S119 11/19/2021
XIENCE PRIME SV Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S116 03/24/2021
XIENCE Alpine Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S115 06/25/2021
SYNERGY™, SYNERGY™ XD and SYNERGY MEGATRON™ Everol... BOSTON SCIENTIFIC CORPORATION P150003 S074 05/27/2021
SYNERGY™ Everolimus-Eluting Platinum Chromium Coro... BOSTON SCIENTIFIC CORPORATION P150003 S081 12/17/2021
SYNERGY™ Everolimus-Eluting Platinum Chromium Coro... BOSTON SCIENTIFIC CORPORATION P150003 S080 12/16/2021
SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimu... BOSTON SCIENTIFIC CORPORATION P150003 S070 03/05/2021
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