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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 NameBAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Supplement NumberS007
Date Received11/15/2010
Decision Date02/18/2011
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a name change to the currently marketed bausch & lomb soflens 66 toric (alphafilcon a) visibility tinted contact lenses. The proposed name for the device is bausch & lomb soflens toric (alphafilcon a) visibility tinted contact lenses.
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