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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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Final Crimp Stopper EDWARDS LIFESCIENCES, LLC. P140031 S058 12/11/2017
Sapien 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S057 12/11/2017
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S056 11/13/2017
SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S055 11/27/2017
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S054 10/03/2017
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S053 10/04/2017
Sapien 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S052 09/28/2017
Sapien 3 - Transcatheter Heart Valve and Accessori... EDWARDS LIFESCIENCES, LLC. P140031 S051 08/15/2017
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S050 07/28/2017
Commander Delivery System; Certitude Delivery Syst... EDWARDS LIFESCIENCES, LLC. P140031 S049 07/27/2017
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