BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S011 · Decision Nov 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    Supplement Number
    S011
    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
    November 1, 2000
    Date Received
    July 21, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION OF THE ELECTRODE FOR THE NUCLEUS CI24 COCHLEAR IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM WITH THE FOLLOWING CHANGES TO THE INDICATIONS FOR USE: 1) APPROVAL TO IMPLANT INDIVIDUALS, AGE 18 YEARS AND OLDER, WHO OBTAIN LIMITED BENEFIT FROM AMPLIFICATION AS DEFINED BY TEST SCORES OF <=50% CORRECT IN THE EAR TO BE IMPLANTED, (<=60% IN THE BEST AIDED LISTENING CONDITION) ON TAPE RECORDED TESTS OF OPEN SET SENTENCE RECOGNITION. 2) APPROVAL TO IMPLANT CHILDREN 12 MONTHS OF AGE AND OLDER WHO HAVE BILATERAL PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear