BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Solution, Cleaning / Lubricating, Artificial Eye

    PMA: N13787 · Supplement: S003 · Decision Dec 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Solution, Cleaning / Lubricating, Artificial Eye
    Trade Name
    ENUCLENE(R) OPHTHALMIC SOLUTION
    PMA Number
    N13787
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MSI
    Generic Name
    Solution, cleaning / lubricating, artificial eye
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 10, 1999
    Date Received
    October 25, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134.

    Classifications

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

    Product Code Device Name
    MSI Solution, Cleaning / Lubricating, Artificial Eye