BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Decision Sep 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
    PMA Number
    P970004
    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
    September 29, 1997
    Date Received
    January 30, 1997
    Expedited Review
    Y
    Docket Number
    98M-0037

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC(R) INTERSTIM(R) SACRAL NEVE STIMULATION (SNS)(TM) SYSTEM WHICH INCLUDES THE MODEL 3886 OR 3080 LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7455 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, MODEL 7452 CONTROL MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER), AND MODEL 3065U PNE KIT AND ACCESSORIES. THIS DEVICE IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE IN PATIENT 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