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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 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
Number
Sort by PMA Number [0-9]
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Decision
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Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S100 09/16/2019
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S028 09/16/2019
Synergy Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S053 09/13/2019
Xience Xpedition Everolimus Eluting Coronary Stent... ABBOTT VASCULAR P110019 S107 09/10/2019
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S003 08/29/2019
Promus Premier Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S168 08/20/2019
Synergy Everolimus-Eluting Platinum Chromium Coron... BOSTON SCIENTIFIC CORPORATION P150003 S052 08/20/2019
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S020 08/16/2019
Resolute Integrity Coronary Stent Systems Medtronic Vascular P110013 S099 08/12/2019
Resolute Onyx Coronary Stent Systems MEDTRONIC VASCULAR P160043 S026 08/12/2019
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