|Classification Name||implant, dermal, for aesthetic use|
|Applicant||ANIKA THERAPEUTICS, INC.|
||General & Plastic Surgery
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the change in product trade name. The device, as modified, will be marketed under the trade name elevess and is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).