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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, COEASE SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP000046
Supplement NumberS010
Date Received06/17/2004
Decision Date07/16/2004
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in procedure for the quality control test method (owl monkey test) for staarvisc ii, shellgel and coease.
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