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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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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Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S198 09/22/2021
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S078 09/22/2021
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S114 08/31/2021
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S054 08/31/2021
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S032 08/20/2021
PROMUS Premier and PROMUS Elite Everolimus-Eluting... Boston Scientific Corp. P110010 S197 08/16/2021
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S051 08/13/2021
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S052 08/09/2021
XIENCE Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S117 07/30/2021
ORSIRO Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S018 07/28/2021
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