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

    Percutaneously Delivered Prostheses And Tricuspid Valves

    PMA: P230013 · Supplement: S030 · Decision May 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Percutaneously Delivered Prostheses And Tricuspid Valves
    Trade Name
    Edwards EVOQUE Tricuspid Valve Replacement System
    PMA Number
    P230013
    Supplement Number
    S030
    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
    May 26, 2026
    Date Received
    May 1, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to implement manufacturing modifications to the inflow and outflow skirt components of the tri-leaflet subassembly of the EVOQUE valve

    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