BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S103 · Decision Mar 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    Supplement Number
    S103
    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 21, 2013
    Date Received
    December 24, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TE STERILE SILICONE TEMPLATE (SST) AS A SINGLE USE SURGICAL TOOL TO HELP CHECK THE SIZE OF THE PERIOSTEAL POCKET, THE SHAPE AND DEPTH OF THE IMPLANT WELL, AND APPROPRIATE POSITIONS FOR TIE-DOWN HOLES DURING THE IMPLANT SURGICAL PROCEDURE.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear