BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P880047 · Supplement: S015 · Decision Jun 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    ABSORBABLE ADHESION BARRIER
    PMA Number
    P880047
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 2011
    Date Received
    April 18, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LARGER INTERCEED PRODUCT THAT MEASURES 5¿X6¿ IN SIZE. THE DEVICE, AS MODIFIED, IS INDICATED AS AN ADJUVANT IN OPEN (LAPAROTOMY) GYNECOLOGIC PELVIC SURGERY FOR REDUCING THE INCIDENCE OF POSTOPERATIVE PELVIC ADHESIONS AFTER METICULOUS HEMOSTASIS IS ACHIEVED.

    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