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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 XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S110 07/22/2020
Sapien 3 and Sapien 3 Ultra Transcatheter Heart Va... EDWARDS LIFESCIENCES, LLC. P140031 S107 07/22/2020
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S117 07/22/2020
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S115 05/21/2020
SAPIEN 3 Ultra Transcatheter Heart Valves EDWARDS LIFESCIENCES, LLC. P140031 S114 04/29/2020
Edwards Commander Delivery System, Edwards Certitu... EDWARDS LIFESCIENCES, LLC. P140031 S113 04/17/2020
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S105 04/10/2020
Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valv... EDWARDS LIFESCIENCES, LLC. P140031 S102 04/10/2020
Edwards SAPIEN 3 Transcatheter Heart Valves and Ed... EDWARDS LIFESCIENCES, LLC. P140031 S111 04/01/2020
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S110 03/11/2020
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