BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Supplement: S028 · Decision Jan 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    APILGRAF(GRAFTSKIN)
    PMA Number
    P950032
    Supplement Number
    S028
    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
    January 17, 2002
    Date Received
    October 24, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REMOVAL OF THE CMV IGG ANTIBODY TEST FROM THE ANTEPARTUM MATERNAL DONOR SERUM TESTING PANEL, WHILE CONTINUING TO TEST THE MATERNAL DONOR SERA FOR CMV IGM ANTIBODIES AND THE MASTER CELL BANK FOR CMV VIA PCR.

    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