BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P960028 · Supplement: S032 · Decision Jun 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    SOFT ACRYLIC INTRAOCULAR LENS
    PMA Number
    P960028
    Supplement Number
    S032
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 29, 2010
    Date Received
    July 30, 2009
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE CYCLE TIME FOR THE TUMBLING PROCESS.

    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