BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P080010 · Supplement: S002 · Decision Jun 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS
    PMA Number
    P080010
    Supplement Number
    S002
    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 19, 2009
    Date Received
    April 28, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.

    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