BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P900067 · Supplement: S007 · Decision Jan 20, 2012
    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 SULFUR HEXAFLUORIDE SF6 GAS
    PMA Number
    P900067
    Supplement Number
    S007
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 20, 2012
    Date Received
    December 22, 2011
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    REPLACE THE ION CHROMATOGRAPH FOR QUALITY CONTROL PRODUCT TESTING.

    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