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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 Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S143 03/09/2023
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart... EDWARDS LIFESCIENCES, LLC. P140031 S152 03/08/2023
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart... EDWARDS LIFESCIENCES, LLC. P140031 S151 01/20/2023
Crimper EDWARDS LIFESCIENCES, LLC. P140031 S150 12/12/2022
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S140 11/16/2022
Edwards SAPIEN 3 Transcatheter Heart Valve System ... EDWARDS LIFESCIENCES, LLC. P140031 S149 11/16/2022
Edwards Certitude Introducer Sheath Set EDWARDS LIFESCIENCES, LLC. P140031 S147 10/26/2022
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S148 10/24/2022
Edwards SAPIEN 3™ Transcatheter Heart Valve and Ed... EDWARDS LIFESCIENCES, LLC. P140031 S144 09/23/2022
SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (... EDWARDS LIFESCIENCES, LLC. P140031 S145 09/23/2022
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