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

    Stimulator, Autonomic Nerve, Implanted (Depression)

    PMA: P970003 · Supplement: S186 · Decision Nov 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted (Depression)
    Trade Name
    VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER
    PMA Number
    P970003
    Supplement Number
    S186
    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
    November 20, 2015
    Date Received
    October 9, 2015
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    USE OF A NEW HELIUM LEAK TESTER IN THE MANUFACTURING PROCESS OF PULSE GENERATORS.

    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)