BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S013 · Decision Dec 12, 2007
    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 (IOL)
    PMA Number
    P030002
    Supplement Number
    S013
    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
    December 12, 2007
    Date Received
    November 5, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INCLUSION OF THE MICROSTAAR MSI-PR AND MSI-TR INJECTORS AND MTC-60C CARTRIDGE IN THE PHYSICIAN LABELING FOR THE CRYSTALENS MODELS AT-50SE AND AT-52SE.

    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