BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Supplement: S019 · Decision Nov 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    APLIGRAF(R)(GRAFTSKIN)
    PMA Number
    P950032
    Supplement Number
    S019
    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
    November 19, 2001
    Date Received
    November 3, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PATIENT BROCHURES FOR PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY AND DIABETIC ULCERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND 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 AND FOR USE WITH STANDARD DIABETIC FOOT ULCER CARE FOR THE TREATMENT OF FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS OF GREATER THAN THREE WEEKS DURATION WHICH HAVE NOT ADEQUATELY RESPONDED TO CONVENTIONAL ULCER THERAPY AND WHICH EXTEND THROUGH THE DERMIS BUT WITHOUT TENDON, MUSCLE, CAPSULE OR BONE EXPOSURE.

    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