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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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9600CR Crimper EDWARDS LIFESCIENCES, LLC. P140031 S075 10/19/2018
9600CR Crimper EDWARDS LIFESCIENCES, LLC. P140031 S138 01/04/2022
9600TFX Edwards SAPIEN 3 Transcatheter Heart Valve... EDWARDS LIFESCIENCES, LLC. P140031 S134 09/22/2021
ASCENDRA + DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC. P130009 S039 08/07/2015
ASCENDRA + DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC. P130009 S025 02/25/2015
Ascendra+ and NovaFlex+ Delivery System, Crimper a... EDWARDS LIFESCIENCES, LLC. P130009 S086 03/07/2018
ASCENDRA+ DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC. P130009 S038 09/02/2015
Ascendra+ Delivery System, NovaFlex+ Delivery Syst... EDWARDS LIFESCIENCES, LLC. P130009 S111 09/07/2020
ASCENDRA+ DELIVERY SYSTEM, NOVAFLEX+ DELIVERY SYST... EDWARDS LIFESCIENCES, LLC. P130009 S042 12/11/2015
Ascendra+ Delivery System; Balloon Aortic Valvulop... EDWARDS LIFESCIENCES, LLC. P130009 S080 07/27/2017
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