BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P890027 · Supplement: S030 · Decision Apr 4, 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
    PMA Number
    P890027
    Supplement Number
    S030
    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
    April 4, 1996
    Date Received
    February 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATIONS TO THE AUDIO INPUT SELECTOR (AIS), AN OPTIONAL ACCESSORY FOR THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF REPLACING THE AUGAT, TYPE ASE/F/FO SERIES SWITCHES WITH AUGAT, YPE MMS SERIES SWITCHES AND REMOUNTING RESISTORS R1 AND R2 TO THE SURFACE OF THE PCB

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear