BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Decision May 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    APLIGRAF (GRAFTSKIN)
    PMA Number
    P950032
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision Code
    APCV
    Decision Date
    May 22, 1998
    Date Received
    October 4, 1995
    Expedited Review
    Y
    Docket Number
    98M-0992

    Advisory Committee Statement

    This device is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGR Dressing, Wound And Burn, Interactive