BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Intraocular Lens

    PMA: P960036 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)
    PMA Number
    P960036
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 22, 1997
    Date Received
    October 1, 1996
    Expedited Review
    N
    Docket Number
    98M-0137

    Advisory Committee Statement

    Approval for the MemoryLens(TM) Model U940A ultraviolet-absorbing hydrophilic posterior chamber intraocular lens. This device is indicated for primary implantation for the visual correction of aphakia in patients sixty years of age or older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the 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