BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    PMA: P130016 · Supplement: S052 · Decision Nov 17, 2023
    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 L24 Cochlear Implant System
    PMA Number
    P130016
    Supplement Number
    S052
    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
    November 17, 2023
    Date Received
    March 13, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modification of the approved labeling for the Nucleus® Hybrid™ L24 Cochlear Implant System to reflect the findings of the Post-Approval Study: New Enrollment Study (P130016/PAS002).

    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