BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S020 · Decision Aug 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Lens, Intraocular, Accommodative
    Trade Name
    CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
    PMA Number
    P030002
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    NAA
    Generic Name
    Lens, intraocular, accommodative
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 5, 2011
    Date Received
    June 2, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MARKET CRYSTALENS® MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) WITH A BENZOTRIAZOLE ULTRA-VIOLET (UV) ABSORBER CHROMOPHORE (UVAM). TO BE DESIGNATED AS MODELS AT1UV, AT2UV, HD1UV, HD2UV, AO1UV AND AO2UV.

    Classifications

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

    Product Code Device Name
    NAA Lens, Intraocular, Accommodative