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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.
 
DeviceBIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAltacor Ltd.
Merlin House, Brunel Road
Theale RG7 4
PMA NumberP960011
Date Received05/01/1996
Decision Date07/16/1998
Product Code LZP 
Docket Number 98M-0604
Notice Date 08/17/1998
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S034 
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