BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Supplement: S021 · Decision Dec 21, 2000
    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
    S021
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 21, 2000
    Date Received
    November 21, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE RELATIVE HUMIDITY OF THE LUNAIRE INCUBATORS USED IN THE APLIGRAF MANUFACTURING PROCESS. THE CHANGE WILL DECREASE THE RISK OF BACTERIAL CONTAMINATION DUE TO WATERBORNE ORGANISMS DURING THE MANUFACTURING PROCESS.

    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