BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P960007 · Decision Mar 18, 1997
    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
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision Code
    APCV
    Decision Date
    March 18, 1997
    Date Received
    March 29, 1996
    Expedited Review
    N
    Docket Number
    98M-0993

    Advisory Committee Statement

    APPROVAL FOR THE DERMAGRAFT-TC(TM). THE DEVICE IS INDICATED FOR USE AS A TEMPORARY WOUND COVERING FOR SURGICALLY EXCISED FULL-THICKNESS AND DEEP PARTIAL-THICKNESS THERMAL BURN WOUNDS IN PATIENTS WHO REQUIRE SUCH A COVERING PRIOR TO AUTOGRAFT PLACEMENT

    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