BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P140031 · Supplement: S099 · Decision Jan 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    SAPIEN 3 Ultra Transcatheter Heart Valve System
    PMA Number
    P140031
    Supplement Number
    S099
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 27, 2021
    Date Received
    October 21, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Edwards Costa Rica manufacturing site to manufacture the SAPIEN 3 Ultra transcatheter heart valve (Model 9750TFX, sizes 20mm, 23mm, and 26mm), located at:Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts surFinca 31 y 32Guadalupe, CartagoCosta Rica 30106

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered