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

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Supplement: S024 · Decision Jul 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    APLIGRAF/GRAFTSKIN
    PMA Number
    P950032
    Supplement Number
    S024
    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
    July 16, 2001
    Date Received
    June 18, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO USE AN ADDITIONAL SHIPPING CONTAINER FOR THE APLIGRAF(TM) DEVICE THAT WOULD MAINTAIN PRODUCT INTEGRITY FOR A PERIOD OF 72 HOURS. THE CHANGE WILL ALLOW FOR GREATER FLEXIBILITY WITH DOMESTIC SHIPMENTS BY ENSURING PRODUCT INTEGRITY FOR A LONGER PERIOD, AND REDUUCE WASTE.

    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