BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S027 · Decision Jul 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    SEPRAFILM ADHESION BARRIER
    PMA Number
    P950034
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 11, 2007
    Date Received
    January 6, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SEPRAFILM ADHESION BARRIER AND IS INDICATED FOR USE IN PATIENTS UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA SUCH AS OMENTUM, SMALL BOWEL, BLADDER, AND STOMACH, AND BETWEEN THE UTERUS AND SURROUNDING STRUCTURES SUCH AS TUBES AND OVARIES, LARGE BOWEL, AND BLADDER.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCN Barrier, Absorbable, Adhesion