BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P000046 · Supplement: S024 · Decision Jun 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE
    PMA Number
    P000046
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 24, 2014
    Date Received
    June 2, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE QUALITY CONTROL METHOD FOR REDUCED TESTING FOR ANIKA¿SOPHTHALMIC DEVICES: STAARVISC, OPTIVISC, NUVISC, AND ANIKAVISC SODIUM HYALURONATE AT THE POSTFILL STAGE.

    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