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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(TM) 1% SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic opthalmo-surgical aid agent
Regulation Number886.4275
ApplicantBIO-TECHNOLOGY GENERAL CORP.
PMA NumberP960011
Supplement NumberS006
Date Received09/27/2000
Decision Date03/08/2001
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the cleaning in place and sterilization in place processes and introduce an equilibration step in the manufacturing of biolon(tm).
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