BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P830056 · Supplement: S078 · Decision Jan 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)
    PMA Number
    P830056
    Supplement Number
    S078
    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
    January 29, 1998
    Date Received
    July 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5. These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens