BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150048 · Supplement: S094 · Decision May 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm
    PMA Number
    P150048
    Supplement Number
    S094
    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
    May 26, 2026
    Date Received
    November 18, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for various design modifications to the TRIFORMIS RESILIA Tricuspid Valve sewing ring.

    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