BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P900066 · Supplement: S003 · Decision Mar 16, 2000
    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
    PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
    PMA Number
    P900066
    Supplement Number
    S003
    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
    March 16, 2000
    Date Received
    September 21, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    1)Change in manufacturing site; 2)Alternate synthesis route for perfluoropropane; and 3) Changing release specification for the perfluoropropane gas.

    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