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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 59 Results
productcode NPT PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Device
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PMA
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EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Cathet... Medtronic, Inc. P130021 S070 12/17/2019
LOTUS Edge Valve System Boston Scientific Corporation P180029 S018 12/17/2019
Lotus Edge Valve System Boston Scientific Corporation P180029 S019 12/11/2019
Evolut R and Evolut PRO Medtronic, Inc. P130021 S064 12/10/2019
EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Cathet... Medtronic, Inc. P130021 S069 12/10/2019
Lotus Edge Valve System Boston Scientific Corporation P180029 S003 12/06/2019
Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra... EDWARDS LIFESCIENCES, LLC. P140031 S101 11/26/2019
Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S104 11/24/2019
Sapien 3 Transcatheter Heart Valve and Ultra Trans... EDWARDS LIFESCIENCES, LLC. P140031 S100 11/24/2019
LOTUS Edge Valve System Boston Scientific Corporation P180029 S017 11/21/2019
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