BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Intraocular

    PMA: P950018 · Supplement: S001 · Decision Dec 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Fluid, Intraocular
    Trade Name
    PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
    PMA Number
    P950018
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LWL
    Generic Name
    Fluid, intraocular
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 11, 1996
    Date Received
    October 17, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE STABILITY PROTOCOL TO INCREASE THE ACCEPTANCE CRITERIA LIMIT FOR UV/VIS ABSORBANCE ON ACCELERATED AGIN (45 DEGREES C) SAMPLES FROM <0.2 TO <0.4 ABSORBANCE UNITS CM-1 AT 220NM

    Classifications

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

    Product Code Device Name
    LWL Fluid, Intraocular