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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
Number
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Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S105 12/21/2020
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S040 12/21/2020
EluNIR Ridaforolimus Eluting Coronary Stent System Medinol, Ltd. P170008 S031 12/21/2020
Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S185 12/16/2020
XIENCE Sierra Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S114 12/16/2020
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S068 12/16/2020
Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S186 12/08/2020
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S069 12/08/2020
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S030 12/08/2020
Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S183 11/30/2020
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