BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P840024 · Supplement: S062 · Decision May 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
    PMA Number
    P840024
    Supplement Number
    S062
    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
    May 20, 1996
    Date Received
    April 24, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE EXTERNAL TRANSMITTER COIL OF THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF CONNECTING TWO DIODES IN PARALLEL WITH THE EXTERNAL TRANSMITTER COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPALNT BY THE COIL. A CHANGE IN THE MANUFACTURING METHOD FOR THE COIL WINDINGS WILL ALSO REDUCE THE EFFECTIVE COIL DIAMETER BY APPROXIMATELY 0.1MM.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear