BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P960033 · Decision Jul 2, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    STAARVISC TM SODIUM HYALURONATE
    PMA Number
    P960033
    Advisory Committee
    Neurology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 2, 1999
    Date Received
    September 23, 1996
    Expedited Review
    N
    Docket Number
    99M-4693

    Advisory Committee Statement

    Approval for the STAARVISC(TM) Sodium Hyaluronate Viscoelastic. This device is indicated for use as a surgical aid in ophthalmic anterior and posterior segment surgery including: 1) Cataract extraction with or without implantation of an intraocular lens; 2) Corneal transplant surgery; 3) Glaucoma filtering surgery; and Secondary lens implantation. STAARVISC(TM) aids in maintaining a deep anterior chamber during surgery, protecting corneal endothelial and surrounding tissues from touch by instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments.