BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S033 · Decision Aug 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC
    PMA Number
    P810031
    Supplement Number
    S033
    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 30, 2007
    Date Received
    December 11, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DIFFERENT RELEASE AGENT TO BE USED WITH THEIR EXISTING PETG MATERIAL IN THE OUTER BLISTER TRAY FOR THE SECONDARY PACKAGING OF ALL OF THE HEALON OPHTHALMIC VISCOELASTIC PRODUCTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE AND IS INTENDED TO BE INTRODUCED INTO THE EYE TO AID PERFORMANCE OF SURGERY, SUCH AS TO MAINTAIN ANTERIOR CHAMBER DEPTH, PRESERVE TISSUE INTEGRITY, PROTECT TISSUE FROM SURGICAL TRAUMA, OR FUNCTION AS A TAMPONADE DURING RETINAL REATTACHMENT.

    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