BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P960007 · Supplement: S008 · Decision Aug 14, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    TRANSCYTE
    PMA Number
    P960007
    Supplement Number
    S008
    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
    August 14, 1998
    Date Received
    July 10, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changing the name of the product from Dermagraft-TC to TransCyte(TM) and for minor editoral changes to the Directions for Use and product label. The device, as modified, will be marketed under the trade name TransCyte(TM) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.

    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