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: S006 · Decision May 5, 2026
    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
    S006
    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
    May 5, 2026
    Date Received
    November 25, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for the addition of an alternate test method (Bacterial Endotoxin Testing Chromogenic) for endotoxin testing of the Implantable Pulse Generator (IPG) and IPG Accessory Kit components of the Altius System and a change in the test lab supplier for endotoxin testing from Integer Uruguay to Labcorp and Integer Plymouth.

    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