BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N16895 · Supplement: S084 · Decision Jan 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    SOFLENS (POLYMACON) CONTACT LENSES
    PMA Number
    N16895
    Supplement Number
    S084
    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
    January 30, 1997
    Date Received
    October 1, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING MODIFICTIONS TO SOFLENS(R) (POLYMACON) CONTACT LENSES INCLUDING THE FOLLOWING LENS TYPES (SERIES): 03, 04, OCCASIONS(TM) MULTIFOCAL, OPTIMA(TM) 38, OPTIMA(TM) 38/SP, U3, U4, SOFSPIN(TM), H03, H04, B3, B4, P.A.1, F3, H3, H4, N, NATURALTINE, OPTIMA(TM) FW, AND SEEQUENCE(TM). MODIFICATIONS INCLUDE: 1)REMOVING THE REPLACEMENT SYSTEM DESCRIPTORS FROM LABELING SPECIFIC TO THE OPTIMA(TM) FW CONTACT LENSES; 2)ADDING MONOVISIO FITTING TECHNIQUE FOR ALL BAUSCH & LOMB SOFLENS(R) (POLYMACON) CONTACT LENSES IN THIS SUPPLEMENT;3)CONSOLIDATING INFO IN SIX FITTING GUIDES INTO 3 FITTING GUIDES FOR SOFLENS(R), NATURALTINT(R), OCCASIONS(TM) MULTIFOCAL, AND P.A.1 CONTACT LENSES; 4)CONSOLIDATING 2 PATIENT INFO BOOKLETS (1 FOR FREQUENT REPLACEMENT USE AND 1 FOR DISPOSABLE USE) FOR SEEQUENCE(TM) (POLYMACON) VISIBILITY TINTED CONTACT LENSES INTO A SINGLE PATIENT INFO BOOKLET (THIS MODIFICATION RESULTS IN DELETION OF THE DISPOSABLE WEAR INDICATION); 5)FORMATTING CHANGES TO PACKAGE INSERTS, FITTING FUIDES & PATIENT INFO BOOKLETS TO BRING LABELING UP-TO-DATE WITH RECOMMENDATIONS IN CDRH'S CURRENT LABELING GUIDANCE; AND 6)SEPARATING THE THERAPEUTIC INDIATION FROM THE COSMETIC LABELING INCLUDED IN THIS SUPPLEMENT.

    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