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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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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