BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S029 · Decision Aug 4, 2005
    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 FOREMAN NEEDLE
    PMA Number
    P970004
    Supplement Number
    S029
    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
    August 4, 2005
    Date Received
    August 30, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) SHIPMENT OF PATIENT CABLE (MODEL 041831) AFTER MANUFACTURING TO MEDTRONIC NEUROLOGICAL DIVISION, SULLIVAN LAKE FACILITY, MINNEAPOLIS, MINNESOTA, FOR CLEANING, PACKAGING AND ETHYLENE OXIDE STERILIZATION, 2) EXTENSION OF THE CURRENT 2-YEAR SHELF LIFE OF THE PATIENT CABLE TO 4 YEARS USING ETHYLENE OXIDE STERILIZATION AND 3) LABELING CHANGES THAT INVOLVE COMBINING THE SEPARATE MANUALS FOR THE MODEL 3065U KIT AND THE MODEL 3057 LEAD INTO ONE MANUAL AND TO REPLACE THE COMBINED MANUAL FOR MODELS 041831, 041829, 041828, 041827 AND 041826 WITH SEPARATE SINGLE SHEET IFUS (INFORMATION FOR USE).

    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