BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P950034 · Supplement: S047 · Decision Jun 29, 2017
    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
    S047
    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
    June 29, 2017
    Date Received
    December 23, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revision of product labeling to update information that is to be provided to patients and physicians about the risks associated with use of Seprafilm®. The revisions include contraindication statements regarding use of Seprafilm® in patients with a history of hypersensitivity to Seprafilm® and against use of Seprafilm® being wrapped directly around a fresh anastomotic suture or staple line. Additional product labeling includes new warnings regarding the use of Seprafilm® in patients with infections in the abdominopelvic cavity, patients with abdominopelvic malignancies, the placement of Seprafilm® in locations other than directly associated with the surgical incision lines, use in patients with ongoing local and/or systemic inflammatory cell responses, Seprafilm® use in the presence of other implants, and use in patients requiring re-operation within a 4 week, post-operative period. Furthermore, the change of a current precaution to a warning regarding potential foreign body reactions to Seprafilm® was identified. Finally, the current precaution noting that safety and effectiveness information for use of Seprafilm® in pregnant women has been revised to specifically include pregnant patients undergoing Cesarean section surgical procedures.

    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