BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P000046 · Supplement: S001 · Decision Jun 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    SHELLGEL(TM) SODIUM HYALURONATE
    PMA Number
    P000046
    Supplement Number
    S001
    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
    June 11, 2001
    Date Received
    May 10, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH CYTOSOL OPHTHALMICS, INC. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SHELLGEL(TM) SODIUM HYALURONATE.

    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