BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P960007 · Supplement: S016 · Decision Dec 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
    PMA Number
    P960007
    Supplement Number
    S016
    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 26, 2001
    Date Received
    November 5, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CEASING OF ENROLLMENT OF NEW PATIENTS IN THE POST-MARKET APPROVAL STUDY: TC-01-07-0597 "AN OPEN LABEL STUDY TO EVALUATE THE INCIDENCE OF WOUND INFECTION IN PATIENTS REQUIRING A TEMPORARY COVERING FOR EXCISED BURN WOUNDS"

    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