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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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PMA
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EDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE EDWARDS LIFESCIENCES, LLC. P130009 S066 05/01/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S068 04/03/2017
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P130009 S069 01/19/2017
SAPIEN XT Transcatheter Heart Valve (Frame only) A... EDWARDS LIFESCIENCES, LLC. P130009 S070 03/09/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S071 04/07/2017
NovaFlex+ Delivery System EDWARDS LIFESCIENCES, LLC. P130009 S072 04/20/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S073 05/10/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S074 05/23/2017
Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S076 06/20/2017
Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S077 06/22/2017
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