|Trade Name||ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL|
|Classification Name||inhibitor, peridural fibrosis (adhesion barrier)|
|Generic Name||inhibitor, peridural fibrosis (adhesion barrier)|
|Supplement Type||special (immediate track)|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to procedures used for the manufacture and testing of the device. 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.