BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P900066 · Supplement: S008 · Decision Feb 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gases Used Within Eye To Place Pressure On Detached Retina
    Trade Name
    ISPAN PERFLUOROPROPANE C3F8
    PMA Number
    P900066
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LPO
    Generic Name
    Gases used within eye to place pressure on detached retina
    Regulation Number
    886.4270
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 19, 2009
    Date Received
    July 21, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGE OF PERFLUOROPROPANE GAS SUPPLIER.

    Classifications

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

    Product Code Device Name
    LPO Gases Used Within Eye To Place Pressure On Detached Retina