|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||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the modification of the manufacturing process for hyalgan for producing hyaluronate by a bacterial fermentation 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.