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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAltacor , Ltd.
Merlin House, Brunel Rd.
Theale RG7 4AB
PMA NumberP960011
Supplement NumberS004
Date Received04/11/2000
Decision Date03/23/2001
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CIBA VISION TO MARKET BIOLON(TM) 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY IN THE UNITED STATES UNDER THE TRADE NAME "UNIVISC".
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