|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 the addition of the following precaution statement to the synvisc physician package insert: "twist the gray tip cap before pulling it off, as this will minimize product leakage".