BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P980006 · Supplement: S002 · Decision Nov 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
    PMA Number
    P980006
    Supplement Number
    S002
    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
    Approved
    Decision Code
    APPR
    Decision Date
    November 23, 1999
    Date Received
    September 1, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for: 1) adding a contraindication for the use of Allergan Ultracare disinfecting System to the product labeling (package insert/fitting guide and patient information booklet for frequent replacement wear); 2) removing references to thermal disinfection in the product labeling (package insert and patient information booklets); and 3) adding "The BAUSCH & LOMB(R) PureVision(TM) (balafilcon A) Visibility Tinted Contact Lenses are manufactured by a cast-molding process and are surface treated by the Performa(TM) surface treatment process which transforms hydrophobic silicone to hydrophilic silicate" to the Description section of the package insert/fitting guide.

    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