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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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41 to 50 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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Medtronic CoreValve(TM) Evolut (TM) R System Medtronic, Inc. P130021 S031 05/16/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S073 05/10/2017
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S038 05/10/2017
Medtronic CoreValve System Medtronic, Inc. P130021 S034 05/09/2017
EDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE EDWARDS LIFESCIENCES, LLC. P130009 S066 05/01/2017
SAPIEN 3 TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P140031 S025 05/01/2017
NovaFlex+ Delivery System EDWARDS LIFESCIENCES, LLC. P130009 S072 04/20/2017
Medtronic CoreValve and Medtronic Evolut Systems Medtronic, Inc. P130021 S037 04/20/2017
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S037 04/19/2017
Medtronic CoreValve Evolut R Transcather Aortic Va... Medtronic, Inc. P130021 S036 04/13/2017
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