BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S166 · Decision Dec 18, 2024
    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
    S166
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 18, 2024
    Date Received
    November 18, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for relocation of a supplier manufacturing facility and manufacturing changes to a surgical tool used with HiRes™ Ultra CI HiFocus™ MS Electrode, HiRes™ Ultra 3D CI HiFocus™ MS Electrode and HiFocus™ Mid-Scala Electrode Insertion Tool Kit

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear