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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSOFLENS (POLYMACON) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberN16895
Supplement NumberS084
Date Received10/01/1996
Decision Date01/30/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order 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.
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