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

    Lenses, Soft Contact, Extended Wear

    PMA: P080011 · Supplement: S011 · Decision May 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
    PMA Number
    P080011
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 11, 2012
    Date Received
    March 30, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REVALIDATION OF BIOFINITY MANUFACTURING LINE #4 WITH THE FOLLOWING MANUFACTURING CHANGES: 1) AN INCREASE IN TEMPERATURE OF THE BARREL HEATER ON THE INJECTION MOLDING MACHINE; AND 2) A CONSOLIDATION CHANGE IN THE DESIGN OF THE FILL AND CLOSE MODULE.

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear