BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P970031 · Supplement: S076 · Decision Nov 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    Freestyle Bioprosthesis
    PMA Number
    P970031
    Supplement Number
    S076
    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
    November 10, 2025
    Date Received
    August 13, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for implementation of updates to the product labels and IFUs, and the implementation of a new temperature indicator on the secondary package shelf cartons for the Mosaic, Hancock II, Avalus, and Freestyle bioprostheses

    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