BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P840024 · Supplement: S046 · Decision Aug 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 22 CHANNEL COCHLEAR
    PMA Number
    P840024
    Supplement Number
    S046
    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
    August 21, 1995
    Date Received
    August 28, 1992
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    95M-0398

    Advisory Committee Statement

    APPROVAL FOR NUCLEUS 22-CHANNEL COCHLEAR IMPLANT FOR USE IN AN EXPANDED ADULT POPULATION.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear