BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P850059 · Supplement: S024 · Decision Aug 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)
    PMA Number
    P850059
    Supplement Number
    S024
    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
    August 13, 2003
    Date Received
    June 11, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens