BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P000046 · Decision Apr 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    STAARVISC II
    PMA Number
    P000046
    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
    April 18, 2001
    Date Received
    November 6, 2000
    Expedited Review
    N
    Docket Number
    01M-0227

    Advisory Committee Statement

    APPROVAL FOR REFERENCE RIGHTS TO P810025, AND FOR STAAR SURGICAL COMPANY TO DISTRIBUTE THE SODIUM HYALURONATE UNDER THE TRADENAME STAARVISC(TM) II. THE DEVICE IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE. PROCEDURES INCLUDE: CATARACT EXTRACTION, INTRAOCULAR LENS (IOL) IMPLANTATION, CORNEAL TRANSPLANTATION SURGERY, GLAUCOMA FILTERING SURGERY AND SURGICAL PROCEDURES TO REATTACH THE RETINA. STAARVISC9TM) II IS DESIGNED TO CREATE AND MAINTAIN ANTERIOR CHAMBER DEPTH AND VISIBILITY, PROTECT CORNEAL ENDOTHELIAL CELLS AND OTHER INTRAOCULAR TISSUES, MINIMIZE INTERATION BETWEEN TISSUES DURING SURGICAL MANIPULATION, AND ACT AS A VITREOUS SUBSTITUTE DURING RETINAL REATTACHMENT SURGERY. STAARVISC(TM) II ALSO PRESERVES TISSUE INTEGRITY AND GOOD VISIBILITY WHEN USED TO FILL THE ANTERIOR AND POSTERIOR SEGMENTS OF THE EYE FOLLOWING OPEN SKY PROCEDURES.

    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