BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Decision Jun 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    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 25, 1998
    Date Received
    November 3, 1997
    Expedited Review
    N
    Docket Number
    98M-0711

    Advisory Committee Statement

    INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATIONTO ADULTS AND CHILDREN VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear