BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P000036 · Supplement: S008 · Decision Apr 18, 2012
    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
    S008
    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
    April 18, 2012
    Date Received
    March 13, 2012
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING SITES LOCATED AT FLEXMEDICAL, IN TIJUANA, BAJA CALIFORNIA, MEXICO AND ADVANCED BIOHEALING INC., IN SAN DIEGO, CALIFORNIA.

    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