BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P870013 · Supplement: S015 · Decision May 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL
    PMA Number
    P870013
    Supplement Number
    S015
    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
    May 8, 2001
    Date Received
    September 21, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens