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

    Implant, Corneal, Refractive

    PMA: P980031 · Supplement: S002 · Decision Jan 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implant, Corneal, Refractive
    Trade Name
    INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
    PMA Number
    P980031
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LQE
    Generic Name
    Implant, corneal, refractive
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 12, 2000
    Date Received
    December 23, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.

    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