BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950018 · Supplement: S004 · Decision Jun 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    PERFLUORON
    PMA Number
    P950018
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    LWL
    Generic Name
    Fluid, intraocular
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 15, 2000
    Date Received
    February 17, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FILTER STERILIZATION AND ASEPTIC FILL FACILITY LOCATED AT CHESAPEAKE BIOLOGICAL LABORATORIES (CBL), IND., BALTIMORE, MARYLAND 21230.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular