BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    PMA: P240011 · Decision Sep 18, 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
    Medtronic Altaviva System
    PMA Number
    P240011
    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
    September 18, 2025
    Date Received
    April 4, 2024
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic Altaviva System is indicated for treatment of urge urinary incontinence (UUI) in patients who failed or could not tolerate more conservative treatments.

    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