BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S104 · Decision Jul 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL Cochlear Implant System
    PMA Number
    P000025
    Supplement Number
    S104
    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
    July 19, 2019
    Date Received
    July 30, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    19M-3513

    Advisory Committee Statement

    Approval for expanding the cochlear implantation indications to include patients 5 years and above with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear