BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Corneal, Refractive

    PMA: P980031 · Supplement: S012 · Decision Jun 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implant, Corneal, Refractive
    Trade Name
    INTACS CORNEAL IMPLANTS
    PMA Number
    P980031
    Supplement Number
    S012
    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
    June 3, 2013
    Date Received
    December 12, 2012
    Supplement Type
    135 Review Track For 30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    TRANSFER OF DISTRIBUTION, PRODUCT RELEASE, SECONDARY LABELING AND PACKAGING, AND LIMITED SECONDARY LABELING AND SECONDARY PACKAGING REWORK OPERATIONS FROMTHE FIRMS CURRENT FACILITY TO ITS NEW FACILITY.

    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