BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P960007 · Supplement: S009 · Decision Dec 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    TRANSCYTE (DERMAGRAFT-TC)
    PMA Number
    P960007
    Supplement Number
    S009
    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
    December 1, 1998
    Date Received
    July 24, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics. The product release criteria of the ATP assay stipulate that production lots of TransCyte will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.

    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