|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|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes in the label: 1) the addition of the trade name, hyalectin, for sodium hyaluronate in the device description; and 2) modifications to the contraindications, warnings and precautions to enhance the appropriate usage of the device.