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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.
 
DeviceDURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP830037
Supplement NumberS040
Date Received12/18/1996
Decision Date05/15/1997
Withdrawal Date02/27/2019
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD AN ULTRA VIOLET ABSORBER TO THE CLEAR AND LITETINE LATHE CUT POLYMER RODS FOR THE SUBJECT DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES DURASOFT(R)3 AND DURASOFT(R)3 UV (PHEMFILCON A) SPHERICAL AND OPTIFIT(R) TORIC CLEAR, LITETINT, COLORS, AND COLOR COMPLEMENTS SOFT (HYDROPHILIC) CONTACT LENSES (LATHE CUT) FOR EXTENDED WEAR WITH NO CHANGE IN THE CURRENTLY APPROVED INDICATIONS FOR USE.
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