BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implantable, For Incontinence

    PMA: P970004 · Supplement: S221 · Decision Aug 5, 2016
    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
    Supplement Number
    S221
    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 5, 2016
    Date Received
    July 8, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the labeling to correct and modify instructions regarding the use of the cycling feature and its impact on battery longevity.

    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