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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 63 Results
productcode NIQ PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Device
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PMA
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Decision
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SLENDER Sirolimus-Eluting Coronary Stent Integrate... Svelte Medical Systems, Inc. P210014 12/13/2021
ORSIRO Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S020 12/09/2021
ORSIRO Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S018 07/28/2021
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S017 07/13/2021
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S016 05/06/2021
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S015 04/23/2021
ORSIRO Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S014 02/17/2021
Orsiro Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S007 06/24/2021
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S036 06/16/2021
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S035 04/16/2021
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