BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    PMA: P130016 · Supplement: S012 · Decision Jul 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
    Trade Name
    NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
    PMA Number
    P130016
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    PGQ
    Generic Name
    Cochlear implant with combined electrical stimulation and acoustic amplification
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 8, 2016
    Date Received
    November 23, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides appropriate instructions for the following Cochlear-manufactured implants: CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), CI24RE(ST), CI24R(CA), CI24R(CS), CI24R(ST), CI24M, and CI 11+11+2M.

    Classifications

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

    Product Code Device Name
    PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification