|Trade Name||ADCON-L ADHESION CONTROL IN A BARRIER GEL|
|Classification Name||inhibitor, peridural fibrosis (adhesion barrier)|
|Generic Name||inhibitor, peridural fibrosis|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - shelf-life|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for extending the expiration dating for adcon-l adhesion control in a barrier gel syring configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.