BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Percutaneously Delivered Prostheses And Tricuspid Valves

    PMA: P230013 · Decision Feb 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Percutaneously Delivered Prostheses And Tricuspid Valves
    Trade Name
    Edwards EVOQUE Tricuspid Valve Replacement System
    PMA Number
    P230013
    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
    February 1, 2024
    Date Received
    March 31, 2023
    Expedited Review
    N
    Docket Number
    24M-0303

    Advisory Committee Statement

    Approval for the Edwards EVOQUE Tricuspid Valve Replacement System. The device is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy (OMT), in whom tricuspid valve replacement is deemed appropriate by a heart team.

    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