BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S031 · Decision Aug 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
    PMA Number
    P810031
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 16, 2007
    Date Received
    September 29, 2006
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRANSFER AND EXPANSION OF THE QUALITY CONTROL MICROBIOLOGY LABORATORY USED FOR THE HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES. THE TRANSFER INCLUDES TEST METHODS, PERSONNEL, AND EQUIPMENT FROM BUILDING 16 TO BUILDING 23 LOCATED IN UPPSALA, SWEDEN.

    Classifications

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

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic