BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Auditory Brainstem

    PMA: P000015 · Supplement: S026 · Decision Feb 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Implant, Auditory Brainstem
    Trade Name
    Nucleus Auditory Brainstem Implant System
    PMA Number
    P000015
    Supplement Number
    S026
    Device Class
    FDA Class 3
    Product Code
    MHE
    Generic Name
    Implant, auditory brainstem
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 14, 2018
    Date Received
    August 25, 2017
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of coupons for residual gas analysis (RGA) testing for hermeticity and to remove the requirement of batch release based on RGA testing.

    Classifications

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

    Product Code Device Name
    MHE Implant, Auditory Brainstem