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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 42 Results
productcode NPT 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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Medtronic CoreValve Evolut R Transcatheter Aortic ... Medtronic, Inc. P130021 S107 12/16/2021
Portico™ Transcatheter Heart Valve Abbott Medical P190023 S004 12/16/2021
Portico TAVI System Abbott Medical P190023 S003 12/13/2021
Medtronic CoreValve™ EnVeo™ R Delivery Catheter Sy... Medtronic, Inc. P130021 S106 12/01/2021
Edwards SAPIEN 3™ Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S137 11/18/2021
Portico Heart Valve, FlexNav Delivery System, Flex... Abbott Medical P190023 S001 11/12/2021
Edwards SAPIEN 3 transcatheter heart valve EDWARDS LIFESCIENCES, LLC. P140031 S136 10/28/2021
Medtronic CoreValve™ Evolut™ R Transcatheter Aorti... Medtronic, Inc. P130021 S104 10/21/2021
Medtronic Evolut™ Pro+ Transcatheter Delivery Cath... Medtronic, Inc. P130021 S105 10/19/2021
Edwards SAPIEN 3™ Transcatheter Heart Valve and SA... EDWARDS LIFESCIENCES, LLC. P140031 S135 10/12/2021
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