BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S033 · Decision Jun 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM
    PMA Number
    P970004
    Supplement Number
    S033
    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
    June 30, 2006
    Date Received
    September 30, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INTERSTIM NEUROSTIMULATOR (MODEL 3058 INTERSTIM II), PATIENT PROGRAMMER (MODEL 3037 ICON), THERAPY APPLICATION SOFTWARE, TINED LEADS (MODELS 3889/3093), SYSTEM ACCESSORIES (MODEL 37092 EXTERNAL ANTENNA, TORQUE HEX WRENCH, TUNNELING TOOL), AND LABELING ARCHITECTURE.

    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