BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P940022 · Supplement: S023 · Decision Sep 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)
    PMA Number
    P940022
    Supplement Number
    S023
    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
    September 9, 2002
    Date Received
    July 29, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE). IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear