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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 NameMODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP910061
Supplement NumberS003
Date Received08/07/1998
Decision Date03/08/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturings qualification protocol and a manufacturing site located at 21 park place blvd. , n. , clearwater, fl 33759.
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