BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S027 · Decision May 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL
    PMA Number
    P970051
    Supplement Number
    S027
    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
    May 18, 2004
    Date Received
    October 6, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ELECTRODE INSERTION TOOL TO FACILITATE PLACEMENT OF THE ELECTRODE INTO THE COCHLEA AS WELL AS MINOR MODIFICATIONS TO THE SOFTIP ELECTRODE TO OPTIMIZE ITS INTERACTION WITH THE INSERTION TOOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSERTION TOOL FOR THE NUCLEUS 24 CONTOUR ADVANCE/SOFTIP ELECTRODE II.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear