BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P900066 · Supplement: S005 · Decision Jan 29, 2002
    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
    S005
    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
    January 29, 2002
    Date Received
    December 26, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING MODIFICATIONS TO IMPROVE THE PATIENT'S AND DOCTOR'S KNOWLEDGE REGARDING THE HAZARDS OF USING NITROUS OXIDE FOR A SUBSEQUENT SURGICAL PROCEDURE WHEN GAS IS STILL PRESENT IN THE EYE.

    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