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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 (HYDROPHILLIC) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
PMA NumberP830037
Supplement NumberS041
Date Received07/06/1998
Decision Date05/20/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the durasoft(r) 3 uv (phemfilcon a) spherical and optifit toric clear, handling tint, colors, and color complements soft (hydrophilic) contact lens (lathe cut) for extended wear to incorporate the pigment carbazole violet as a handling tint at wesley jessen - cidra operation, road 173, km 1. 1, cidra, pr 00739. The pigment will be incorporated as an in-monomer tint by entrapment.
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