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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 332 Results
Applicant EDWARDS LIFESCIENCES, LLC. productcode NPT Decision Date To 05/10/2024
 
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PMA
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TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORI... EDWARDS LIFESCIENCES, LLC. P100041 S033 07/11/2013
Sapien XT Transcatheter Heart Valve and Accessorie... EDWARDS LIFESCIENCES, LLC. P130009 S100 09/17/2019
SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIE... EDWARDS LIFESCIENCES, LLC. P130009 S037 02/29/2016
SAPIEN XT Transcatheter Heart Valve (Frame only) A... EDWARDS LIFESCIENCES, LLC. P130009 S070 03/09/2017
Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S077 06/22/2017
Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S076 06/20/2017
SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P130009 S003 08/07/2014
SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P130009 S005 08/07/2014
SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P130009 S032 04/13/2015
SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P130009 S010 09/29/2014
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