BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N17987 · Supplement: S027 · Decision Nov 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    CSI (CROFILCON A) EXTENDED WEAR SOFT
    PMA Number
    N17987
    Supplement Number
    S027
    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 18, 1999
    Date Received
    September 1, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site transfer of the CTL process for the CSI(TM) Lens from San Diego, CA to Wesley Jessen, Inc., Route 173, Kilometer 1.1, El Jibaro Industrial Park, P.O. Box 1980, Cidra, Puerto Rico 00739.

    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