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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 49 Results
productcode NIQ PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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Orsiro Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S028 12/21/2023
Xience Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S130 12/15/2023
PROMUS Element Plus and Promus PREMIER and Promus ... Boston Scientific Corp. P110010 S212 12/12/2023
EluNIR-PERLTM Ridaforolimus Eluting Coronary Stent... Medinol, Ltd. P170008 S047 12/08/2023
XIENCE Sierra Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S129 11/21/2023
EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent ... Medinol, Ltd. P170008 S046 11/21/2023
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S074 11/01/2023
XIENCE Alpine Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S128 10/27/2023
Orsiro Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S034 10/26/2023
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S037 10/20/2023
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