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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
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic opthalmo-surgical aid agent
Regulation Number886.4275
ApplicantBIO-TECHNOLOGY GENERAL CORP.
PMA NumberP960011
Supplement NumberS002
Date Received03/29/1999
Decision Date07/01/1999
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the biolon(tm) syringes.
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