BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Corneal, Refractive

    PMA: P980031 · Supplement: S013 · Decision Sep 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implant, Corneal, Refractive
    Trade Name
    INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
    PMA Number
    P980031
    Supplement Number
    S013
    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
    September 9, 2024
    Date Received
    October 2, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at AJL Ophthalmic, S.A., Ferdinand Zeppelin 1, Parque Tecnologico Alava, 01510 Minano, Araba, Spain, for manufacturing segment components, inspection, cleaning and primary packaging and sterilization of INTACS Corneal Implants

    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