BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    PMA: P080025 · Decision Mar 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
    Trade Name
    MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
    PMA Number
    P080025
    Device Class
    FDA Class 3
    Product Code
    QON
    Generic Name
    Implanted electrical device intended for treatment of fecal incontinence
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 14, 2011
    Date Received
    September 26, 2008
    Expedited Review
    N
    Docket Number
    11M-0175

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC INTERSTIM THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF CHRONIC FECAL INCONTINENCE IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence