BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Supplement: S009 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Lens, Intraocular, Accommodative
    Trade Name
    EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
    PMA Number
    P030002
    Supplement Number
    S009
    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 29, 2007
    Date Received
    March 5, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR RECOMMENDATION TO USE THE STAAR MSI-PF INJECTOR AND MTC-60C CARTRIDGE SYSTEM FOR INJECTING THE CRYSTALENS MODELS AT-45 & AT-45SE) TO BE ADDED TO THE PHYSICIAN 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