BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S005 · Decision Sep 26, 2005
    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
    S005
    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
    September 26, 2005
    Date Received
    August 23, 2005
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN THE ?RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES? SECTION OF THE PHYSICIANS LABELING.

    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