|
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 | S006 |
Date Received | 03/12/1999 |
Decision Date | 04/21/1999 |
Withdrawal Date
|
05/09/2007 |
Product Code |
MLQ |
Advisory Committee |
Physical Medicine |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syring configurations from 6 months to 12 months. 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. |