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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 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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Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S050 07/28/2017
Ascendra+ Delivery System; Balloon Aortic Valvulop... EDWARDS LIFESCIENCES, LLC. P130009 S080 07/27/2017
Commander Delivery System; Certitude Delivery Syst... EDWARDS LIFESCIENCES, LLC. P140031 S049 07/27/2017
EDWARDS SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S079 07/20/2017
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S046 07/20/2017
Edwards SAPIEN XT™ Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S078 07/18/2017
Edwards SAPIEN 3™ Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S045 07/18/2017
Medtronic CoreValve System/ Evolut R System/ Evolu... Medtronic, Inc. P130021 S039 07/17/2017
CoreValve System; CoreValve Evolut R System; CoreV... Medtronic, Inc. P130021 S033 07/10/2017
EnVeo R Delivery Catheter System Medtronic, Inc. P130021 S038 06/28/2017
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