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

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Supplement: S035 · Decision Apr 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Totally Implanted
    Trade Name
    Model 7010 Sensor and Model 7510 Driver transducers
    PMA Number
    P090018
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    OAF
    Generic Name
    Implant, hearing, active, middle ear, totally implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 14, 2017
    Date Received
    March 17, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change in a component supplier and a manufacturing process change for the Model 7010 Sensor and Model 7510 Driver transducers.

    Classifications

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

    Product Code Device Name
    OAF Implant, Hearing, Active, Middle Ear, Totally Implanted