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

    Implant, Cochlear

    PMA: P960058 · Supplement: S148 · Decision May 28, 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
    S148
    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
    May 28, 2020
    Date Received
    April 29, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Facility move for the current supplier for manufacturing of the Printed Circuit Board Assemblies (PCBAs) for the Ultra Family of Implants, and the qualification of an alternate supplier to assemble the PCBAs for the Ultra 3D Implants.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear