BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S003 · Decision Nov 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
    PMA Number
    P970004
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    EZW
    Generic Name
    Stimulator, electrical, implantable, for incontinence
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 2, 1998
    Date Received
    August 3, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for marketing the Medtronic(R) Model 3057 Test Stimulation Lead Bulk Accessory/Medtronic(R) Model 3065U Test Stimulation Lead Kit for use with the Medtronic(R) Interstim(R) Continence Control System which is inidcated for the treatment of urinary urge 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
    EZW Stimulator, Electrical, Implantable, For Incontinence