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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 SODIUM HYALURONATE
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP030019
Supplement NumberS009
Date Received05/08/2006
Decision Date10/26/2007
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifying the manufacturing process for orthovisc to one that produces sodium hyaluronate from bacterial fermentation. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).
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