BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P230020 · Decision Aug 26, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Trade Name
    Altius® Direct Electrical Nerve Stimulation System
    PMA Number
    P230020
    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
    August 26, 2024
    Date Received
    June 30, 2023
    Expedited Review
    N

    Advisory Committee Statement

    Approval order for Altius® Direct Electrical Nerve Stimulation System. This device is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees.