BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P990015 · Decision Nov 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    INTERGEL ADHESION PREVENTION SOLUTION
    PMA Number
    P990015
    Device Class
    FDA Class 3
    Product Code
    MCN
    Generic Name
    Barrier, absorbable, adhesion
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 16, 2001
    Date Received
    March 8, 1999
    Expedited Review
    Y
    Docket Number
    01M-0523

    Advisory Committee Statement

    APPROVAL FOR THE GYNECARE INTERGEL ADHESION PREVENTIION SOLUTION. THE DEVICE IS INDICATED FOR USE IN PATIENTS UNDERGOING OPEN, CONSERVATIVE GYNECOLOGIC SURGERY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE TO REDUCE POST-SURGICAL ADHESIONS. GYNECARE INTERGEL ADHESION PREVENTION SOLUTION IS ALSO INTENDED TO REDUCE THE LIKELIHOOD OF DEVELOPING MODERATE OR SEVERE POSTOPERATIVE ADNEXAL ADHESIONS IN THESE PATIENTS.

    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