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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 65 Results
productcode NPT PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Device
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PMA
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Core Valve Evolut R System and Core Valve Evolut P... Medtronic, Inc. P130021 S048 12/12/2017
CoreValve Evolut R System and CoreValve Evolut Pro... Medtronic, Inc. P130021 S047 12/11/2017
Sapien 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S057 12/11/2017
Final Crimp Stopper EDWARDS LIFESCIENCES, LLC. P140031 S058 12/11/2017
SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S083 11/27/2017
SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S055 11/27/2017
CoreValve Evolut R System and CoreValve Evolut PRO... Medtronic, Inc. P130021 S046 11/21/2017
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES EDWARDS LIFESCIENCES, LLC. P140031 S047 11/20/2017
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES EDWARDS LIFESCIENCES, LLC. P140031 S048 11/20/2017
CoreValve, Evolut-R Evolut PRO Medtronic, Inc. P130021 S045 11/16/2017
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