BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P890027 · Supplement: S032 · Decision Jun 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
    PMA Number
    P890027
    Supplement Number
    S032
    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
    June 13, 1996
    Date Received
    April 25, 1996
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISIONS TO THE WARNING SECTION IN THE PACKAGE INSERT AND PATIENT IDENTIFICATION CARD FOR THE NUCLEUS 22 COCHLEAR IMPLANT SYSTEM. THE REVISIONS CLARIFY THE WARNING ON THE USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES ADD'L INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear