BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    PMA: P080025 · Supplement: S087 · Decision Mar 26, 2015
    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
    INTERSTIM THERAPY SYSTEM
    PMA Number
    P080025
    Supplement Number
    S087
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 26, 2015
    Date Received
    February 27, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURING CHANGE AFFECTING THE COMPONENT OF AN IMPLANTABLE NEUROSTIMULATOR (INS) USED FOR THE MEDTRONIC NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPIES.

    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