BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Fluid, Intraocular

    PMA: P910068 · Decision Sep 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    VITREON(R)
    PMA Number
    P910068
    Device Class
    FDA Class 3
    Product Code
    LWL
    Generic Name
    Fluid, intraocular
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 30, 1997
    Date Received
    December 6, 1991
    Expedited Review
    Y
    Docket Number
    97M-0519

    Advisory Committee Statement

    Approval for VITREON(R) (Perfluorophenanthrene) Intraocular Fluid. This device is indicated for use as an intraoperative surgical aid during vitreoretinal surgery inpatients with primary and recurrent complicated reinal detachments. Complicated cases include giant retinal tear or retinal dialysis, proliferative vitreoretinopathy, proliferative diabetic reinopathy, tractional retinal detachments, and blunt or penetrating ocular trauma. We are pleased to inform you that the PMA is approved for a single batch (Batch #672-45-0001) of the finished product packaged in sterile 6 mL vials.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular