BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950018 · Supplement: S026 · Decision Nov 28, 2023
    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
    S026
    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
    November 28, 2023
    Date Received
    November 3, 2023
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for the addition of a warning and precaution to the Perfluoron Indications for Use

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular