BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P990080 · Supplement: S002 · Decision Sep 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000
    PMA Number
    P990080
    Supplement Number
    S002
    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
    September 24, 2002
    Date Received
    September 13, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW TRADE NAME FOR THE MODEL Z9000 FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS, AND OTHER LENS MODELS WHICH INCORPORATE THE MODIFIED PROLATE ANTERIOR OPTIC SURFACE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNIS, WITH Z-SHARP OPTIC TECHNOLOGY AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION. THE LENS IS INTENDED TO BE PLACED 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