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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 45 Results
productcode NIQ PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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PMA
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XIENCE Alpine Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S122 09/14/2022
Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S204 09/01/2022
Orsiro Sirolimus Eluting Coronary Stent System, Or... Biotronik, Inc P170030 S022 08/31/2022
PROMUS PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S201 08/18/2022
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
Resolute Integrity Coronary Stent System Medtronic Vascular P110013 S109 07/15/2022
Resolute Onyx Coronary Stent Systems MEDTRONIC VASCULAR P160043 S045 07/15/2022
XIENCE Skypoint Everolimus Eluting Coronary Stent ... ABBOTT VASCULAR P110019 S121 06/22/2022
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S061 06/15/2022
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