BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030016 · Supplement: S036 · Decision Apr 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    Visian ICL (Implantable Collamer Lens)
    PMA Number
    P030016
    Supplement Number
    S036
    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
    April 15, 2019
    Date Received
    November 2, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modification to the labeling for the Visian® Implantable Collamer® Lens, Models MICL and TMICL to reflect the findings of the Adverse Event Post-approval Study for the Visian® MICL

    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