BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    PMA: P210007 · Decision Aug 27, 2021
    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
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 27, 2021
    Date Received
    March 2, 2021
    Expedited Review
    N
    Docket Number
    21M-0991

    Advisory Committee Statement

    Approval the MicroTransponder® Vivistim® Paired VNS System (Vivistim ® System) is intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.

    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