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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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51 to 59 of 59 Results
productcode NIQ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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PMA
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ORSIRO Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 02/22/2019
XIENCE V and XIENCE nano Everolimus Eluting Corona... ABBOTT VASCULAR INC. P070015 S144 02/20/2019
XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Ev... ABBOTT VASCULAR P110019 S104 02/20/2019
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S012 02/15/2019
PROMUS Element Plus Everolimus Eluting Platinum Ch... Boston Scientific Corp. P110010 S162 02/14/2019
SYNERGY Everolimus Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S046 02/14/2019
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S011 02/13/2019
Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S161 01/17/2019
Resolute Onyx Zotarolimus Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S013 01/17/2019
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