BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P010019 · Supplement: S001 · Decision Jul 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
    PMA Number
    P010019
    Supplement Number
    S001
    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
    July 5, 2002
    Date Received
    April 5, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE. THE POST-APPROVAL STUDY PROTOCOL WAS SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE OCTOBER 11, 2001 APPROVAL ORDER FOR P010019.

    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