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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSOFLENS66(TM)
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
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 S009 
S010 S011 
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