BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P170006 · Decision Jul 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    AVALUS(TM) BIOPROSTHESIS
    PMA Number
    P170006
    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
    July 31, 2017
    Date Received
    February 2, 2017
    Expedited Review
    N
    Docket Number
    17M-4756

    Advisory Committee Statement

    Approval for the Avalus Bioprosthesis, Model 400. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic 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