BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Percutaneously Delivered Prostheses And Tricuspid Valves

    PMA: P230013 · Supplement: S025 · Decision Apr 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Percutaneously Delivered Prostheses And Tricuspid Valves
    Trade Name
    Edwards EVOQUE Tricuspid Valve Replacement System
    PMA Number
    P230013
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    NPW
    Generic Name
    Percutaneously Delivered Prostheses and Tricuspid Valves
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 10, 2026
    Date Received
    March 11, 2026
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a labeling update to add a warning against deploying the valve if the delivery system’s functionality is compromised.

    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