BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S010 · Decision Aug 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    CI24R(ST) COCHLEAR IMPLANT
    PMA Number
    P970051
    Supplement Number
    S010
    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
    August 21, 2000
    Date Received
    February 23, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN MODIFICATION INCLUDING THE STRAIGHT ELECTRODE OF THE CI 24 M WITH THE 24 K DOWNSIZED STIMULATOR RECEIVER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CI 24R(ST), AND IS INDICATED FOR CHILDREN AGE 18 MONTHS THROUGH 17 YEARS OF AGE WHO HAVE BILATERAL PROFOUND SENSORINEURAL DEAFNESS AND DEMONSTRATE LITTLE OR NO BENEFIT FROM APPROPRIATE BINAURAL HEARING AIDS, AND FOR ADULTS, AGE 18 YEARS AND OLDER WHO HAVE BILATERAL MODERATE TO PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATE 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