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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 63 Results
productcode NIQ PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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PMA
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Resolute Integrity RX Zotarolimus-Eluting Coronary... Medtronic Vascular P110013 S111 05/21/2021
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S047 05/21/2021
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S024 05/21/2021
SYNERGY Everolimus Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S075 05/18/2021
XIENCE Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S113 05/13/2021
Promus Premier and Promus Elite Everolimus-Eluting... Boston Scientific Corp. P110010 S192 05/12/2021
Resolute Integrity Zotarolimus Eluting Coronary St... Medtronic Vascular P110013 S110 05/11/2021
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S046 05/11/2021
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S016 05/06/2021
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S073 04/29/2021
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