|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 Name||SYNVISC (HYLAN G-F 20)|
|Classification Name||acid, hyaluronic, intraarticular|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to the physician package insert. The device, as modified, will be marketed under the trade name synvisc(r) (hylan g-f 20) 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.