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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 61 Results
productcode NIQ PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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Device
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PMA
Number
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Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S091 12/20/2018
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORON... BOSTON SCIENTIFIC CORPORATION P150003 S045 12/20/2018
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S088 12/14/2018
Synergy Monorail Everolimus-Eluting Platinum Chrom... BOSTON SCIENTIFIC CORPORATION P150003 S044 12/14/2018
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S012 12/14/2018
XIENCE Sierra RX Everolimus Eluting Coronary Stent... ABBOTT VASCULAR P110019 S103 11/20/2018
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S010 11/16/2018
Promus ELITE Everolimus-Eluting Platinum Chromium ... Boston Scientific Corp. P110010 S160 10/31/2018
Resolute Integrity Zotarolimus Eluting Coronary St... Medtronic Vascular P110013 S090 10/18/2018
SYNERGY Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S039 10/18/2018
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