BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P970034 · Supplement: S009 · Decision Jun 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    POSTERIOR CHAMBER IOL'S
    PMA Number
    P970034
    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 29, 2001
    Date Received
    April 19, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. TO PRIVATE-LABEL ITS PMA-APPROVED POSTERIOR-CHAMBER INTRAOCULAR LENSES FOR DISTRIBUTION IN THE UNITED STATES BY CIBA VISION CORPORATION. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE-NAMES, CIBA VISION INTRAOCULAR LENS MODELS 0420F, 0455F, 0440U, 0840U, 0430M, 0840Z2, AND 0840Z, AND ARE INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER, WHO ARE UNDERGOING EXTRACAPSULAR EXTRACTION AND PRIMARY LENS IMPLANTATION.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens