BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950018 · Supplement: S008 · Decision Jul 29, 2002
    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
    S008
    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
    July 29, 2002
    Date Received
    December 26, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING BLISTER PACKAGING TO THE VIAL PRODUCT THAT IS THEN SUBJECTED TO A STEAM STERILIZATION PROCESS IN ORDER TO PROVIDE A FINISHED PRODUCT VIAL WITH A STERILE EXTERIOR. ALSO, APPROVAL OF A 10 ML VIAL FOR THE 7 ML FILL PRODUCT TO ALLOW STERILIZATION HEADSPACE.

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular