BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N18033 · Supplement: S034 · Decision May 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS
    PMA Number
    N18033
    Supplement Number
    S034
    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
    May 18, 2001
    Date Received
    November 3, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING THE MANUFACTURING FACILITY AT VISTAKON, JOHNSON & JOHNSON (IRELAND) LTE., LIMERICK, IRELAND, FOR THE MANUFACTURE OF ACCUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENSES.

    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