BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S009 · Decision Jun 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL)
    PMA Number
    P930014
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 2003
    Date Received
    December 26, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS (MODEL SB30AL). THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICA-TION ARE PERFORMED. THESE LENSES ARE INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens