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

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    PMA: P130016 · Supplement: S037 · Decision Mar 8, 2019
    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 Implant System
    PMA Number
    P130016
    Supplement Number
    S037
    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
    March 8, 2019
    Date Received
    January 30, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New wash solution for cleaning of the electronic assembly after solder operations.

    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