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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 NameBIOLON 1% SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic opthalmo-surgical aid agent
Regulation Number886.4275
ApplicantFERRING PHARMACEUTICALS, INC.
PMA NumberP960011
Supplement NumberS011
Date Received10/02/2006
Decision Date09/13/2007
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in inflammation testing for bulk sodium hyaluronate from oxidative burst testing to an il-6 elisa method.
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