BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P000036 · Supplement: S002 · Decision Mar 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    DERMAGRAFT
    PMA Number
    P000036
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 19, 2002
    Date Received
    March 5, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE CAUTION STATEMENT IN THE DIRECTIONS FOR USE FROM "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE" TO "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE INDICATED ON THE LABELED UNIT CARTON."

    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