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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.
 
DeviceCOEASE SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Anika Therapeutics, Inc.
32 wiggins avenue
bedford, MA 01730
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 - indications/instructions/shelf life/tradename
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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