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

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P870024 · Supplement: S046 · Decision Apr 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Rigid Gas Permeable), Extended Wear
    Trade Name
    PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B)
    PMA Number
    P870024
    Supplement Number
    S046
    Device Class
    FDA Class 3
    Product Code
    MWL
    Generic Name
    Lens, contact (rigid gas permeable), extended wear
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 29, 2009
    Date Received
    March 30, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING MATERIALS.

    Classifications

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

    Product Code Device Name
    MWL Lens, Contact (Rigid Gas Permeable), Extended Wear