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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 NameCOEASE SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP000046
Supplement NumberS003
Date Received04/17/2002
Decision Date05/08/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a private distributor agreement with advanced medical optics. The device will be marketed under the trade name coease sodium hyaluronate and will be distributed in volumes of 0. 5 ml and 0. 8 ml.
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