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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.
 
Trade NameDURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses for extended wear
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberP830037
Supplement NumberS040
Date Received12/18/1996
Decision Date05/15/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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