|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|
|Applicant||ANIKA THERAPEUTICS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to expand the specification for residual methanol in monovisc from <= 0. 05% to <= 0. 03% w/w to be in accordance with residual solvent testing limits under usp general chapter <467>, to revise the stability testing protocol for monovisc, and to extend the shelf life of monovisc from 2 years to 3 years utilizing this revised stability testing protocol.