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

    Implant, Cochlear

    PMA: P960058 · Supplement: S118 · Decision Sep 18, 2015
    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
    S118
    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
    September 18, 2015
    Date Received
    August 21, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN LOCATION OF THE SUPPLIER OF RAW POLYETHYLENE MATERIALUSED TO MANUFACTURE BRAIDED FIBER THAT IS THEN USED IN THE HIRES 90KTM ADVANTAGE ANTENNA COIL, AND EXPANDED MATERIAL SPECIFICATIONS FOR BOTH THE RAW FIBER AND THE BRAIDED FIBER.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear