BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P820049 · Supplement: S061 · Decision Jul 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    MODELS PC-58NBM & PC-58NBZ IOLS
    PMA Number
    P820049
    Supplement Number
    S061
    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
    July 28, 1995
    Date Received
    April 4, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR STERILIZATION OF LENSES USING PREVIOUSLY APPROVED 100% (ETO) STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE-POUCH/100% ETO STERILIZED LENSES

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens