BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030016 · Supplement: S045 · Decision Oct 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
    PMA Number
    P030016
    Supplement Number
    S045
    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
    October 1, 2024
    Date Received
    April 12, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for labeling updates related to PAS “CP22-01 Postmarket Evaluation of the EVO ICL"

    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