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

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    PMA: P210007 · Supplement: S010 · Decision Jan 28, 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® System
    PMA Number
    P210007
    Supplement Number
    S010
    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
    January 28, 2026
    Date Received
    January 20, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MicroTransponder has revised the following material supplier information for the Vivistim Paired VNS System (P210007): Change #1: The supplier of the Model 3000 Implantable Lead Polyester Suture has introduced a new sub-supplier of the polyester fiber subcomponent of the sutures due to discontinuation of the raw material from the original sub-supplier.Change #2: The supplier of EPO-TEK-301 has introduced a new sub-supplier of a subcomponent (Part A) of the two-part EPO-TEK-301 epoxy due to discontinuation of the raw material from the original sub-supplier.

    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