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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 45 Results
productcode NIQ PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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Device
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PMA
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SLENDER Sirolimus-Eluting Coronary Stent Integrate... Svelte Medical Systems, Inc. P210014 S001 04/08/2022
BioFreedom Drug Coated Coronary Stent System Biosensors International USA, P190020 04/14/2022
Orsiro Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S026 08/05/2022
Orsiro Sirolimus Eluting Coronary Stent System, Or... Biotronik, Inc P170030 S024 07/27/2022
Orsiro Sirolimus Eluting Coronary Stent System, Or... Biotronik, Inc P170030 S022 08/31/2022
ORSIRO Sirolimus Eluting Coronary Stent System and... Biotronik, Inc P170030 S021 02/23/2022
ORSIRO Sirolimus Eluting Coronary Stent System, OR... Biotronik, Inc P170030 S019 02/18/2022
EluNIR Ridaforolimus Eluting Coronary Stent System Medinol, Ltd. P170008 S041 04/19/2022
EluNIR TM Ridaforolimus Eluting Coronary Stent Sys... Medinol, Ltd. P170008 S040 04/14/2022
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S039 04/20/2022
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