BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P870013 · Supplement: S008 · Decision May 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
    PMA Number
    P870013
    Supplement Number
    S008
    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
    May 1, 1996
    Date Received
    October 31, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE FOLLOWING: IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens