BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P000036 · Decision Sep 28, 2001
    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
    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
    September 28, 2001
    Date Received
    August 25, 2000
    Expedited Review
    N
    Docket Number
    01M-0498

    Advisory Committee Statement

    APPROVAL FOR THE DERMAGRAFT(R). THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF FULL-THICKNESS DIABETIC FOOT ULCERS GREATER THAN SIX WEEKS DURATION WHICH EXTEND THROUGH THE DERMIS, BUT WITHOUT TENDON MUSCLE, JOINT CAPSULE OR BONE EXPOSURE. DERMAGRAFT(R) SHOULD BE USED IN CONJUNCTION WITH STANDARD WOUND CARE REGIMENS AND IN PATIENTS THAT HAVE ADEQUATE BLOOD SUPPLY TO THE INVOLVED FOOT.

    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