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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 NameORTHOVISC
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP030019
Supplement NumberS017
Date Received11/03/2010
Decision Date03/18/2011
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the sample preparation of raw material hyaluronate acid to be changed from its current formulation to a more diluted test sample.
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