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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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Sapien 3 Ultra Transcatheter Heart Valve with the ... EDWARDS LIFESCIENCES, LLC. P140031 S104 03/10/2020
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S108 03/05/2020
Sapien 3 Transcatheter Heart Valve and Accessories EDWARDS LIFESCIENCES, LLC. P140031 S108 03/05/2020
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S109 03/05/2020
SAPIEN 3 Ultra Transcatheter Heart Valve System (T... EDWARDS LIFESCIENCES, LLC. P140031 S105 01/16/2020
Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra... EDWARDS LIFESCIENCES, LLC. P140031 S101 11/26/2019
Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S104 11/24/2019
Sapien 3 Transcatheter Heart Valve and Ultra Trans... EDWARDS LIFESCIENCES, LLC. P140031 S100 11/24/2019
Edwards Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S101 11/04/2019
Edwards Sapien XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S103 10/28/2019
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