BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P040020 · Supplement: S007 · Decision Feb 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    ACRYSOF RESTOR INTRAOCULAR LENSES
    PMA Number
    P040020
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 6, 2008
    Date Received
    December 20, 2007
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF INFORMATION: 1) CLARIFYING THE OPTIKOS MODULATION TRANSFER FUNCTION (MTF) TEST PROCEDURE THAT WAS REVISED; 2) PROVIDING THE SUPPLEMENTARY DATA AND VALIDATION DATA FOR THE SOFTWARE OF THE OPTIKOS MTF BENCH; AND 3) PROVIDING THE SOFTWARE VALIDATION FOR THE ADDITIONAL OPTIKOS MTF SYSTEM TO TEST MULTIFOCAL LENSES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MFK Lens, Multifocal Intraocular