BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P230020 · Supplement: S004 · Decision Jun 5, 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
    S004
    Product Code
    SAZ
    Generic Name
    stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 5, 2025
    Date Received
    May 9, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes in the ethylene oxide (EO) sterilization cycle parameters, including optimization of EO concentration, for the Nerve Cuff Electrode of the Altius System