BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    PMA: P200036 · Decision Mar 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
    Trade Name
    eCoin Peripheral Neurostimulator
    PMA Number
    P200036
    Device Class
    FDA Class 3
    Product Code
    QPT
    Generic Name
    Stimulator, tibial, electrical, implantable, for urinary incontinence
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 2022
    Date Received
    August 10, 2020
    Expedited Review
    N
    Docket Number
    22M-0298

    Advisory Committee Statement

    Approval of the eCoin® Peripheral Neurostimulator. The device is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence