BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P960028 · Supplement: S010 · Decision Aug 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS
    PMA Number
    P960028
    Supplement Number
    S010
    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
    August 25, 2003
    Date Received
    August 6, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."

    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