BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150048 · Supplement: S092 · Decision Oct 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    TRIFORMIS RESILIA Tricuspid Valve
    PMA Number
    P150048
    Supplement Number
    S092
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 27, 2025
    Date Received
    April 30, 2025
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the MITRIS RESILIA Mitral Valve for expanding the indications to include the tricuspid position. The device, as modified, will be marketed under the trade name “TRIFORMIS RESILIA Tricuspid Valve” and is indicated for the replacement of native or prosthetic tricuspid heart valves.

    Classifications

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

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue