BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    PMA: P200036 · Supplement: S009 · Decision Oct 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
    Trade Name
    eCoin Tibial Nerve Stimulator System
    PMA Number
    P200036
    Supplement Number
    S009
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 2, 2025
    Date Received
    September 10, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in supplier for the Printed Circuit Board Assembly (PCBA)

    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