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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSOFLENS66(TM)
Classification Namelenses, soft contact, extended wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Date Received06/28/1996
Decision Date12/16/1996
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 97M-0183
Notice Date 05/22/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the bausch & lomb(r) soflens66(tm) (alphafilcon a) visibility tinted contact lens for extended wear.
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 
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