Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
• Generic Name: Inhibitor, peridural fibrosis (adhesion barrier)
• Applicant: Wrightmedicaltechnologyinc; 5677 Airline Rd.; Arlington, TN 38002
• PMA Number: P960057
• Date Received: 12/23/1996
• Decision Date: 05/27/1998
• Withdrawal Date: 05/09/2007
• Product Code: MLQ
• Docket Number: 98M-0404
• Notice Date: 06/23/1998
• Advisory Committee: Neurology
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for ADCON(R)-L Adhesion Barrier Gel. This device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.

• Supplements: S011 S001 S002 S003 S004 S005 S006 S008