BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S183 · Decision Jun 14, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    Cochlear Nucleus CI600 Series Cochlear Implants
    PMA Number
    P970051
    Supplement Number
    S183
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 14, 2019
    Date Received
    December 17, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new series of Nucleus Cochlear Implants, the CI600 Series Cochlear Implants, comprising the CI612, CI622 and CI632, and two accessories (Nucleus Non-Magnetic Cassette and Nucleus Replacement Magnet Cassette).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear