BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted (Depression)

    PMA: P970003 · Supplement: S170 · Decision Feb 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted (Depression)
    Trade Name
    VNS THERAPY SYSTEM
    PMA Number
    P970003
    Supplement Number
    S170
    Device Class
    FDA Class 3
    Product Code
    MUZ
    Generic Name
    Stimulator, autonomic nerve, implanted (depression)
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 12, 2016
    Date Received
    April 28, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Cyberonics Latam S.L.R., Edificio B49, 51 Ave 0, Zona Franca Coyol, Coyol - Alajuela, Costa Rica facility, in which the site will perform the final assembly, packaging, storing, and distribution of the Implantable Pulse Generators and the Lead Finals.

    Classifications

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

    Product Code Device Name
    MUZ Stimulator, Autonomic Nerve, Implanted (Depression)