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

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    PMA: P210007 · Supplement: S012 · Decision Apr 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
    Trade Name
    Vivistim® Paired VNS™ System
    PMA Number
    P210007
    Supplement Number
    S012
    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
    April 1, 2026
    Date Received
    March 2, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval to implement two manufacturing changes pertaining to the Lead and Can Lids of the Vivistim Paired VNS System

    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