BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P000046 · Supplement: S023 · Decision Apr 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    NUVISC
    PMA Number
    P000046
    Supplement Number
    S023
    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 10, 2014
    Date Received
    January 15, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUVISCTM AND 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.

    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