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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant EDWARDS LIFESCIENCES, LLC. productcode NPT Decision Date To 05/10/2024
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Device
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PMA
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Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart... EDWARDS LIFESCIENCES, LLC. P140031 S141 07/28/2022
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S139 01/23/2022
9600CR Crimper EDWARDS LIFESCIENCES, LLC. P140031 S138 01/04/2022
Edwards SAPIEN 3™ Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S137 11/18/2021
Edwards SAPIEN 3 transcatheter heart valve EDWARDS LIFESCIENCES, LLC. P140031 S136 10/28/2021
Edwards SAPIEN 3™ Transcatheter Heart Valve and SA... EDWARDS LIFESCIENCES, LLC. P140031 S135 10/12/2021
9600TFX Edwards SAPIEN 3 Transcatheter Heart Valve... EDWARDS LIFESCIENCES, LLC. P140031 S134 09/22/2021
SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Va... EDWARDS LIFESCIENCES, LLC. P140031 S130 09/17/2021
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S132 09/03/2021
SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Va... EDWARDS LIFESCIENCES, LLC. P140031 S133 08/31/2021
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