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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 FOR OPHTHALMIC SURGERY)
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic opthalmo-surgical aid agent
Regulation Number886.4275
ApplicantSAVIENT PHARMACEUTICALS, INC
PMA NumberP960011
Supplement NumberS008
Date Received03/18/2002
Decision Date04/01/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization and final cartoning facility located at medical manufacturing corporation, erie, pennsylvania.
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