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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.
 
DeviceMODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910061
Date Received10/08/1991
Decision Date09/02/1994
Product Code HQL 
Docket Number 94M-0339
Notice Date 10/14/1994
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S025 S026 
S027 
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