BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P230020 · Supplement: S002 · Decision May 6, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Trade Name
    Altius Direct Electrical Nerve Stimulation System
    PMA Number
    P230020
    Supplement Number
    S002
    Product Code
    SAZ
    Generic Name
    stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 6, 2025
    Date Received
    February 14, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an Altius Implantable Pulse Generator (IPG) Accessory Kit that includes a spare sterile port plug and torque wrench.