BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P170006 · Supplement: S042 · Decision Feb 4, 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
    Avalus™ Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus™ Ultra Bioprosthesis Model 400 (400U1
    PMA Number
    P170006
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 4, 2026
    Date Received
    January 6, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an alternative batch testing plan for bacterial endotoxin testing

    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