|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|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revisions of the instructions for use (ifu) and the patient information (pi) for supartz as follows: 1) revision in the ifu and pi of the statement, ¿the safety and effectiveness of repeat treatment cycles of supartz have not been established. ¿ to ¿the effectiveness of repeat treatment cycles of supartz has not been established. ¿; and 2) insertion in the ifu and pi of the statements, ¿adverse experience data from the literature contain no evidence of increased safety risk relating to retreatment with supartz. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. ¿.