BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Corneal, Refractive

    PMA: P120023 · Supplement: S002 · Decision Oct 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implant, Corneal, Refractive
    Trade Name
    KAMRA INLAY
    PMA Number
    P120023
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LQE
    Generic Name
    Implant, corneal, refractive
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 2016
    Date Received
    October 28, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of incorporation of a new double tray packaging configuration in order to accommodate physicians' ease of use. The new packaging configuration has currently been validated for a 5-year shelf life. In addition, an alternate sterilization site, Sterigenics US LLC, has been validated for the proposed packaging.

    Classifications

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

    Product Code Device Name
    LQE Implant, Corneal, Refractive