BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S149 · Decision Dec 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    HiResolution Bionic Ear System
    PMA Number
    P960058
    Supplement Number
    S149
    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
    December 2, 2020
    Date Received
    May 4, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the New Sound Processors (Naida CI M30, Naida CI M90, and Sky CI M90), New Headpieces (Slim HP, Slim HP AquaMic, Slim HP Mic, and Slim HP Standard), Target CI, AB Remote, and Accessories (M Battery Small, M Battery Medium, M Battery Large, M Standard Battery, M Waterproof Battery, M Zn-Air Battery Pak, M Acoustic Earhook, M Earhook, M T-Mic, Slim HP Standard Magnet, Slim HP 3D Magnet, M Programming Cable, Slim HP Color Cap, and Slim HP Color Cap large).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear