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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 48 Results
productcode NPT PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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PMA
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Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S124 12/16/2020
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S123 12/13/2020
Evolut R, Pro and Pro+ Systems Medtronic, Inc. P130021 S083 12/08/2020
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S112 11/10/2020
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S121 11/10/2020
LOTUS Edge Valve System Boston Scientific Corporation P180029 S028 11/06/2020
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S122 11/05/2020
EnVeo PRO Delivery Catheter System, EnVeo R Delive... Medtronic, Inc. P130021 S081 10/30/2020
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S109 10/27/2020
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S116 10/27/2020
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