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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 NameSTAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP000046
Supplement NumberS006
Date Received10/15/2002
Decision Date03/18/2003
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 an additional method for endotoxin testing.
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