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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 49 Results
productcode NIQ PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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Device
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PMA
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SYNERGY™ SHIELD Everolimus-Eluting Platinum Chromi... BOSTON SCIENTIFIC CORPORATION P150003 S098 10/17/2023
Resolute Onyx Over The Wire Zotarolimus-Eluting Co... MEDTRONIC VASCULAR P160043 S073 10/12/2023
XIENCE Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S124 10/04/2023
Resolute Onyx RX Zotarolimus-Eluting Coronary Sten... MEDTRONIC VASCULAR P160043 S071 09/28/2023
ORSIRO Sirolimus Eluting Coronary Stent System, Or... Biotronik, Inc P170030 S032 08/25/2023
ORSIRO Sirolimus Eluting Coronary Stent System, Or... Biotronik, Inc P170030 S031 08/24/2023
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S097 08/17/2023
Onyx Frontier Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S066 08/08/2023
ORSIRO Sirolimus Eluting Coronary Stent System, Or... Biotronik, Inc P170030 S030 08/07/2023
PROMUS Element Plus and Promus PREMIER and Promus ... Boston Scientific Corp. P110010 S211 07/27/2023
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