BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S129 · Decision Jun 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    Supplement Number
    S129
    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 23, 2015
    Date Received
    March 23, 2015
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES TO THE CP900 SERIES PROCESSOR COILWHICH MAKES THE CP900 SERIES PROCESSOR COMPATIBLE WITH THE N22 IMPLANT AND ALLOWS RECIPIENTS OF THE N22 IMPLANT ACCESS TO THE NEWEST PROCESSOR TECHNOLOGY.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear