BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Toric Optics

    PMA: P030002 · Supplement: S037 · Decision Feb 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Lens, Intraocular, Toric Optics
    Trade Name
    CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P030002
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    MJP
    Generic Name
    LENS, INTRAOCULAR, TORIC OPTICS
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 9, 2016
    Date Received
    December 18, 2015
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the following changes to the post-approval study for the device: administrative changes, including changes to personnel and organization and changes to the informed consent form.

    Classifications

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

    Product Code Device Name
    MJP Lens, Intraocular, Toric Optics