BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Percutaneously Delivered Prostheses And Tricuspid Valves

    PMA: P230013 · Supplement: S006 · Decision Jul 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Percutaneously Delivered Prostheses And Tricuspid Valves
    Trade Name
    EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System
    PMA Number
    P230013
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    NPW
    Generic Name
    Percutaneously Delivered Prostheses and Tricuspid Valves
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 30, 2024
    Date Received
    July 1, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a new ethylene oxide (EO) sterilization cycle to reduce the EO gas concentration

    Classifications

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

    Product Code Device Name
    NPW Percutaneously Delivered Prostheses And Tricuspid Valves