BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gases Used Within Eye To Place Pressure On Detached Retina

    PMA: P900066 · Supplement: S004 · Decision Sep 5, 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
    S004
    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
    September 5, 2000
    Date Received
    August 18, 2000
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE TOXICITY TEST PROTOCOL TO INCREASE THE NUMBER OF SAMPLES TO BE TESTED FROM EACH PRODUCTION LOT OF PERFLUOROPROPANE FROM ONE SAMPLE PER LOT TO THREE SAMPLES PER LOT.

    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