BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    PMA: P130016 · Supplement: S024 · Decision Apr 21, 2017
    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 Implant System
    PMA Number
    P130016
    Supplement Number
    S024
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 21, 2017
    Date Received
    March 23, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of an alternate Printed Circuit Board (PCB) supplier for the CP800 and CP900 sound processor coils for the Nucleus 24 Cochlear Implant system, the Nucleus Hybrid L24 implant system and the Nucleus ABI541 Auditory Brainstem Implant system.

    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