BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S037 · Decision Jan 19, 2011
    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
    S037
    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
    January 19, 2011
    Date Received
    October 29, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A ¿QUARTER SHEET¿ CONFIGURATION TO THE SEPRAFILM ADHESION BARRIER PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ¿SEPRAFILM 4-SECTION¿ 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