BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S008 · Decision Mar 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Stimulator, Electrical, Implantable, For Incontinence
    Trade Name
    INTERSTIM SYSTEM FOR URINARY CONTROL
    PMA Number
    P970004
    Supplement Number
    S008
    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
    March 9, 2000
    Date Received
    February 29, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1)elimination of the OR screening cable from the Model 3080 and 3886 lead kits, 2) to use the generic term "fluoropolymer" in place of "PTFE," and 3) to make numerous minor revisions to the Physician and Hospital Staff Manual for the Model 3012 Quadripolar Neurostimulator, Models 3080 and 3886 Leads, and Model 3095 Extension.

    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