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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 TM
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
FERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
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 - manufacturer/sterilizer/packager/supplier
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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