BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S024 · Decision Sep 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Lens, Intraocular, Accommodative
    Trade Name
    CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS
    PMA Number
    P030002
    Supplement Number
    S024
    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 8, 2011
    Date Received
    July 14, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE +17 TO +27 POWER RANGE FOR THE CRYSTALENS ACCOMMODATING INTRAOCULAR LENS, MODEL AT52AO.

    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