BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S008 · Decision Mar 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS
    PMA Number
    P000025
    Supplement Number
    S008
    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
    March 25, 2003
    Date Received
    January 21, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES IN THE LABELING: 1) INFORMATIONAL STATEMENTS REGARDING MENINGITIS, THE USE OF PROPHYLACTIC ANTIBIOTICS, AND VACCINATIONS 2) INFORMATIONAL STATEMENTS REGARDING ELECTROSTATIC DISCHARGE (ESD) PREVENTIONS.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear