|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||HEALON(R) SODIUM HYALURONATE|
|Classification Name||aid, surgical, viscoelastic|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the final product release testing requirements for the family of healon(r) sodium hyaluronate viscoelastic products.