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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 HIGH MOLECULAR WEIGHT HYALURON
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP030019
Supplement NumberS001
Date Received02/27/2004
Decision Date08/06/2004
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate raw material source.
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