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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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PMA
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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
Resolute Integrity RX and OTW Zotarolimus-Eluting ... Medtronic Vascular P110013 S113 12/14/2021
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S049 12/14/2021
SLENDER Sirolimus-Eluting Coronary Stent Integrate... Svelte Medical Systems, Inc. P210014 12/13/2021
ORSIRO Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S020 12/09/2021
Resolute Onyx RX Zotarolimus-Eluting Coronary Sten... MEDTRONIC VASCULAR P160043 S056 11/24/2021
XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting C... ABBOTT VASCULAR P110019 S119 11/19/2021
Resolute Integrity RX Zotarolimus-Eluting Coronary... Medtronic Vascular P110013 S115 11/16/2021
SYNERGY XD Everolimus Eluting Platinum Chromium Co... BOSTON SCIENTIFIC CORPORATION P150003 S079 10/04/2021
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