BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P140031 · Supplement: S186 · Decision Jun 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed
    PMA Number
    P140031
    Supplement Number
    S186
    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
    June 4, 2025
    Date Received
    March 28, 2025
    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 a manufacturing site located at Centerpiece S. de. R.L. de C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada 11530, Tijuana, Baja California, 22250, Mexico for sterilization

    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