BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S014 · Decision Jun 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Lens, Intraocular, Accommodative
    Trade Name
    CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520
    PMA Number
    P030002
    Supplement Number
    S014
    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
    June 19, 2008
    Date Received
    December 17, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MARKET THE FOLLOWING MODELS IN 0.5 DIOPTER INCREMENTS: MODELS AT-45-HD100 (10 TO 33 DIOPTERS), HD500 (17.0 TO 33.0 DIOPTERS), AND HD520 (10 TO 16.5 DIOPTERS). ADDITIONALLY, APPROVAL TO RECOMMEND USE OF THE STAAR MSI-PR/TR AND MSI-PF/TF INJECTORS WITH MTC-60C CARTRIDGE TO DELIVER THESE LENS MODELS.

    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