|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.|
|Classification Name||acid, hyaluronic, intraarticular|
|Generic Name||sodium hyaluronate|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for updating the section of adverse events with a qualitative description of the types and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e. G. , acetaminophen.