BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P230020 · Supplement: S003 · Decision Jun 25, 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
    S003
    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
    June 25, 2025
    Date Received
    April 1, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a second battery charge current option of 100 mA, in addition to the battery charge current of 50 mA previously approved under the original PMA P230020.