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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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51 to 60 of 332 Results
Applicant EDWARDS LIFESCIENCES, LLC. productcode NPT Decision Date To 05/10/2024
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PMA
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Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S112 11/10/2020
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S121 11/10/2020
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S122 11/05/2020
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S109 10/27/2020
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S116 10/27/2020
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S120 10/05/2020
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S119 09/25/2020
EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter ... EDWARDS LIFESCIENCES, LLC. P140031 S112 09/09/2020
Ascendra+ Delivery System, NovaFlex+ Delivery Syst... EDWARDS LIFESCIENCES, LLC. P130009 S111 09/07/2020
Commander Delivery System, Certitude Delivery Syst... EDWARDS LIFESCIENCES, LLC. P140031 S118 09/07/2020
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