BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P990014 · Supplement: S004 · Decision Sep 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)
    PMA Number
    P990014
    Supplement Number
    S004
    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 16, 2003
    Date Received
    August 25, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW TRADE NAME FOR THE HP60M HYDROGEL IOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "MERIDIAN" AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE OR OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS. THE LENS IS DESIGNED FOR IMPLANTATION IN THE CAPSULAR BAG FOLLOWING EXTRACAPSULAR CATARACT EXTRACTION.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens