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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
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAltacor Ltd.
Merlin House, Brunel Road
Theale RG7 4
PMA NumberP960011
Supplement NumberS002
Date Received03/29/1999
Decision Date07/01/1999
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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