BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted (Depression)

    PMA: P970003 · Supplement: S169 · Decision Jul 2, 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 GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)
    PMA Number
    P970003
    Supplement Number
    S169
    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
    July 2, 2014
    Date Received
    April 4, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE PRINTED CIRCUIT BOARD ASSEMBLYMANUFACTURING DESIGN REQUIREMENT FOR VOLTAGE MEASUREMENT ACCURACY AND TOLERANCE ASSOCIATED WITH ITS ELECTRICAL TESTING.

    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)