|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||aid, surgical, viscoelastic|
|Applicant||ANIKA THERAPEUTICS, INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new trade name. The device, as modified, will be marketed under the trade name nuvisctm and is indicated for use during surgery in the anterior and posterior segments of the human eye. Procedures include: cataract extraction, intraocular lens (iol) implantation, corneal transplantation surgery, glaucoma filtering surgery, and surgical procedures to reattach the retina.