|Trade Name||ADCON -L ADHESION CONTROL IN A BARRIER GEL|
|Classification Name||inhibitor, peridural fibrosis (adhesion barrier)|
|Generic Name||inhibitor, peridural fibrosis|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the adcon(r)-l adhesion control barrier gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.