BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P960036 · Supplement: S001 · Decision Aug 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    MEMORY LENS MODEL U940A UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
    PMA Number
    P960036
    Supplement Number
    S001
    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
    August 25, 2000
    Date Received
    August 23, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SHELF-LIFE EXTENSION TO 18 MONTHS, A PROPOSED PROTOCOL FOR ADDITIONAL SHEL-LIFE EXTENSIONS, AND A NEW DIMENSIONAL SPECIFICATION.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens