BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

    PMA: P230020 · Supplement: S005 · Decision Dec 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb
    Trade Name
    Altius® Direct Electrical Nerve Stimulation System
    PMA Number
    P230020
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    SAZ
    Generic Name
    stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 3, 2025
    Date Received
    July 7, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at Neuros Medical, Inc., 1212 Red Fox Road, Arden Hills, Minnesota, 55112. The main manufacturing operations performed at this facility include, but are not limited to, the receipt of sterile and non-sterile finished packaged devices ready for distribution from two contract manufacturing organization facilities, evaluation of returned devices, calibration and maintenance of inspection equipment, and serve as the specification developer and design control center.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAZ Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb