|Trade Name||ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL|
|Classification Name||inhibitor, peridural fibrosis (adhesion barrier)|
|Generic Name||inhibitor, peridural fibrosis (adhesion barrier)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested that fda review a change in the manufacturing process. A vertrod thermal impulse heat sealer will be used in place of an audion future jaw clamp pouch sealer to seal the tyvek pouch containing the aluminum tube of adcon(r)-l adhesion control barrier gel. This change does not affect the currently approved tyvek seal integrity testing method or specification.