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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
ApplicantBIO-TECHNOLOGY GENERAL CORP.
PMA NumberP960011
Supplement NumberS003
Date Received08/03/1999
Decision Date09/02/1999
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a manufacturing process change for biolon(tm) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to bio-technology general corporation's fermentation process at the rehovot, israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.
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