BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Corneal, Refractive

    PMA: P980031 · Decision Apr 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implant, Corneal, Refractive
    Trade Name
    INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
    PMA Number
    P980031
    Device Class
    FDA Class 3
    Product Code
    LQE
    Generic Name
    Implant, corneal, refractive
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 9, 1999
    Date Received
    July 14, 1998
    Expedited Review
    N
    Docket Number
    99M-1167

    Advisory Committee Statement

    This device is indicated for the reduction or elimination of mild myopia (-2.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LQE Implant, Corneal, Refractive