BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    PMA: P240011 · Supplement: S004 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
    Trade Name
    Medtronic Altaviva System
    PMA Number
    P240011
    Supplement Number
    S004
    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
    December 19, 2025
    Date Received
    November 21, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    The protocol modifications include the addition of quality-of-life, work productivity, mental health, and sexual health questionnaires. Additional revisions included changing "up to 30 institutions" to "approximately 30 institutions", requirements for appropriate investigator training, education, and experience, and updated language regarding the 6-month washout period for botulinum toxin therapy and sacral neuromodulation.

    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