BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    PMA: P200036 · Supplement: S008 · Decision Jul 16, 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 Peripheral Neurostimulator
    PMA Number
    P200036
    Supplement Number
    S008
    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
    July 16, 2025
    Date Received
    June 20, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for PAS protocol revisions including the addition of sites

    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