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

    Lenses, Soft Contact, Extended Wear

    PMA: P980006 · Supplement: S017 · Decision Dec 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS
    PMA Number
    P980006
    Supplement Number
    S017
    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
    December 27, 2010
    Date Received
    December 1, 2010
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    REDUCTION OF THE SAMPLE SIZE TESTING PHYSICAL PROPERTIES ACCEPTANCE CRITERIA DURING THE USE OF THE AUTOMATED INSPECTION SYSTEM FOR THE PUREVISION (BALAFILCON A) CONTACT LENSES. THIS CHANGE OF THE SAMPLING PLAN APPLIES ONLY TO BAUSCH & LOMB¿S WATERFORD, IRELAND FACILITY.

    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