BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S091 · Decision Dec 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM
    PMA Number
    P000025
    Supplement Number
    S091
    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 20, 2016
    Date Received
    September 22, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to allow a maximum of four re-sterilization cycles after initial sterilization for the following products: Mi1200 SYNCHRONY (PIN) Cochlear Implant, Mi1000 MED-EL CONCERT (PIN) Cochlear Implants, SONATATI100 Cochlear Implants, Insertion Electrodes (IE) and Insertion Test Device (ITD).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear