BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030028 · Supplement: S008 · Decision May 14, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    Artisan Myopia Intraocular Lens
    PMA Number
    P030028
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MTA
    Generic Name
    Lens, intraocular, phakic
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 14, 2019
    Date Received
    February 6, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor labeling changes for the Physician’s Labeling and Patient Brochure.

    Classifications

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

    Product Code Device Name
    MTA Lens, Intraocular, Phakic