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

    Stimulator, Autonomic Nerve, Implanted (Depression)

    PMA: P970003 · Supplement: S181 · Decision Jul 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted (Depression)
    Trade Name
    CYBERONICS VNS THERAPY SYSTEM
    PMA Number
    P970003
    Supplement Number
    S181
    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 31, 2015
    Date Received
    June 22, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF NEW PROCESSES FOR REPROCESSING TABLET COMPUTERS RETURNED FROM THE FIELD AND A PROCESS TO INSTALL PREVIOUSLY APPROVED SOFTWARE UPGRADES ON TABLET COMPUTERS THAT HAVE BEEN DISTRIBUTED TO THE FIELD FOR THE CYBERONICS® VNS THERAPY® SYSTEM TABLET COMPUTERS (MOTION MODEL CL900 OR CYBERONICS MODEL 700, MOTION MODEL CL910 OR CYBERONICS MODEL 720).

    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)