BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P150048 · Supplement: S096 · Decision Feb 6, 2026
    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, Model 11300T
    PMA Number
    P150048
    Supplement Number
    S096
    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
    February 6, 2026
    Date Received
    January 7, 2026
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) titled "Registry-Based Real-World Use Surveillance." The PAS protocol was submitted to comply with the conditions of approval outlined in the approval order for P150048/S092.

    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