BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S054 · Decision Aug 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
    PMA Number
    P810031
    Supplement Number
    S054
    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 25, 2015
    Date Received
    June 11, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO UPDATE THE LABELING FOR THE HEALON5® OPHTHALMIC VISCOSURGICALDEVICE (OVD) TO REMOVE THE PHYSICIAN TRAINING PROGRAM FOR NEW USERS AND TO REVISE THE PRECAUTIONS SECTION OF THE DIRECTIONS FOR USE TO ALLOW FOR OTHER OVD REMOVAL TECHNIQUES.

    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