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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 62 Results
productcode NIQ PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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Device
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PMA
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PROMUS Element Plus, PREMIER and ELITE Everolimus-... Boston Scientific Corp. P110010 S163 01/03/2020
Promus Element Plus Everolimus-Eluting Platinum C... Boston Scientific Corp. P110010 S164 01/03/2020
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S001 01/23/2020
Promus Element Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S174 02/06/2020
Xience Sierra Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S110 02/13/2020
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S027 02/14/2020
PROMUS Elite Everolimus-Eluting Platinum Chromium ... Boston Scientific Corp. P110010 S175 03/02/2020
XIENCE V Everolimus Eluting Coronary Stent System,... ABBOTT VASCULAR INC. P070015 S147 03/12/2020
XIENCE PRIME SV Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S111 03/12/2020
XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONA... ABBOTT VASCULAR INC. P070015 S146 03/19/2020
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