BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Barrier, Absorbable, Adhesion

    PMA: P990015 · Supplement: S002 · Decision Mar 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Barrier, Absorbable, Adhesion
    Trade Name
    GYNECARE INTERGEL ADHESION PREVENTION SOLUTION
    PMA Number
    P990015
    Supplement Number
    S002
    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
    March 18, 2003
    Date Received
    September 19, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE LABELING IN RESPONSE TO ADVERSE EVENT REPORTS OF ADDITIONAL SURGERY, INCLUDING HYSTERECTOMY, THAT OCCURRED FOLLOWING POST-OPERATIVE PAIN, ASCITES, NON-INFECTIOUS PERITONITIS, AND/OR POSSIBLE DELAYED CLEARANCE OF GYNECARE INTERGEL.

    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