BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    PMA: P210007 · Supplement: S006 · Decision May 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
    Trade Name
    Vivistim® System
    PMA Number
    P210007
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    QPY
    Generic Name
    Stimulator, autonomic nerve, implanted for stroke rehabilitation
    Medical Specialty
    Unknown
    Advisory Committee
    Physical Medicine
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 30, 2025
    Date Received
    May 1, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for proposed manufacturing changes, consisting of changes in suppliers of selected components internal to the ViviStim Implantable Pulse Generator (IPG). These component suppliers were previously qualified by the main contract manufacturer and included on their Approved Suppliers List for the supply of raw materials and unfinished components, and they are now qualified to perform additional manufacturing steps that were previously performed by the main contract manufacturer.

    Classifications

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

    Product Code Device Name
    QPY Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation