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

    Stimulator, Autonomic Nerve, Implanted (Depression)

    PMA: P970003 · Supplement: S172 · Decision Jul 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted (Depression)
    Trade Name
    VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304
    PMA Number
    P970003
    Supplement Number
    S172
    Device Class
    FDA Class 3
    Product Code
    MUZ
    Generic Name
    Stimulator, autonomic nerve, implanted (depression)
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 17, 2014
    Date Received
    June 19, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    AUTOMATE A WELD ANGLE MEASUREMENT PROCESS.

    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)