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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 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
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EluNIR Ridaforolimus Eluting Coronary Stent System Medinol, Ltd. P170008 S028 08/20/2020
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S008 08/20/2020
Synergy Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S058 08/10/2020
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S006 06/15/2020
Promus Premier, Promus Elite Everolimus-Eluting Pl... Boston Scientific Corp. P110010 S179 06/09/2020
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S062 06/09/2020
SYNERGY™ XD Everolimus-Eluting Platinum Chromium C... BOSTON SCIENTIFIC CORPORATION P150003 S055 05/28/2020
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S032 05/28/2020
PROMUS Element PLUS/PREMIER/ELITE Everolimus-Eluti... Boston Scientific Corp. P110010 S176 05/19/2020
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S059 05/19/2020
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