BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Supplement: S044 · Decision Jul 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    APLIGRAF
    PMA Number
    P950032
    Supplement Number
    S044
    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
    July 13, 2007
    Date Received
    May 15, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW CELL STRAIN, HEP 040, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR THE TREATMENT OF PARTIAL AND FULL THICKNESS CHRONIC VENOUS ULCERS.

    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