BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950018 · Supplement: S002 · Decision Mar 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    PERFLURON
    PMA Number
    P950018
    Supplement Number
    S002
    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
    March 5, 1999
    Date Received
    February 11, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following changes: use of an alternate Fluorotec S2-F451W stopper; changes in the aseptic filling and packaging processes to use the CBL Autobloc automated filling line; an alternate fill volume (2 ml) for Perfluoron in a unit package; a new Master Batch Record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular