BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S096 · Decision Aug 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
    PMA Number
    P970051
    Supplement Number
    S096
    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 2, 2013
    Date Received
    August 27, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE NUCLEUS 6 COCHLEAR IMPLANT SYSTEM, A NEW SUITE OF EXTERNAL ACCESSORIES AND PROGRAMMING SOFTWARE TO BE USED WITH THE NUCLEUS 24 COCHLEAR IMPLANT, INCLUDING EXTERNAL SOUND PROCESSORS (CP910 AND CP920), USER REMOTE ASSISTANTS (CR210 AND CR230), INTRAOPERATIVE REMOTE ASSISTANT (CR220), AND PROGRAMMING SOFTWARE (CUSTOM SOUND SUITE 4 COMPRISED OF CUSTOM SOUND 4 AND CUSTOM SOUND EP 4).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear