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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 59 Results
productcode NIQ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Device
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PMA
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Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S097 12/18/2019
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S029 12/17/2019
Promus PREMIER/ Promus ELITE Everolimus-Eluting Pl... Boston Scientific Corp. P110010 S173 12/04/2019
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S056 12/04/2019
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S005 12/04/2019
PROMUS PREMIER Everolimus-Eluting Chromium Coronar... Boston Scientific Corp. P110010 S172 11/26/2019
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S057 11/26/2019
EluNIR Ridaforolimus Eluting Coronary Stent System Medinol, Ltd. P170008 S019 11/19/2019
ORSIRO Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S002 11/12/2019
PROMUS Element Plus and Promus PREMIER and Promus ... Boston Scientific Corp. P110010 S171 11/07/2019
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