BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    PMA: P210007 · Supplement: S003 · Decision Aug 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
    Trade Name
    MicroTransponder Vivistim Paired VNS System (Vivistim System)
    PMA Number
    P210007
    Supplement Number
    S003
    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 21, 2024
    Date Received
    June 6, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Your supplement requested approval for changes to the device software to fix several bugs, incorporate patient and clinician feedback, and strengthen the password requirements of the device login.

    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