|
Device | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
Generic Name | Inhibitor, peridural fibrosis (adhesion barrier) |
Applicant | WRIGHTMEDICALTECHNOLOGYINC 5677 AIRLINE RD. ARLINTON, TN 38002 |
PMA Number | P960057 |
Supplement Number | S004 |
Date Received | 02/11/1999 |
Decision Date | 08/11/1999 |
Withdrawal Date
|
05/09/2007 |
Product Code |
MLQ |
Advisory Committee |
Physical Medicine |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a patient brochure. The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis. |