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

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    PMA: P010023 · Supplement: S014 · Decision Oct 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Partially Implanted
    Trade Name
    MAXUM System
    PMA Number
    P010023
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    MPV
    Generic Name
    Implant, hearing, active, middle ear, partially implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 28, 2020
    Date Received
    September 28, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Ethylene oxide (EO) sterilization process change for the implantable Magnet Canister Assembly.

    Classifications

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

    Product Code Device Name
    MPV Implant, Hearing, Active, Middle Ear, Partially Implanted