BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P910068 · Supplement: S001 · Decision Apr 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)
    PMA Number
    P910068
    Supplement Number
    S001
    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
    April 4, 2001
    Date Received
    April 26, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) MANUFACTURING SITE CHANGE: THE NEW SITE FOR MANUFACTURING THE BULK MEDICAL GRADE PERFLUOROPERHYDROPHENANTHRENE (APF-215M) WILL BE AT FLUOROMED, L.P. (FMLP), ROUND ROCK, TEXAS 78664; 2) MANUFACTURING CHANGE: APF-215M WILL BE MANUFACTURED FROM PERFLUOROPERHYDROPHENANTHRENE RAW MATERIAL INSTEAD OF FROM PHENANTHRENE RAW MATERIAL; AND 3) APF-215M SPECIFICATION CHANGE REGARDING TESTING PARAMETER FOR LOWER BOILING COMPONENTS.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular