|
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 | S008 |
Date Received | 05/13/1999 |
Decision Date | 06/02/1999 |
Withdrawal Date
|
05/09/2007 |
Product Code |
MLQ |
Advisory Committee |
Physical Medicine |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for new quality control measures and is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis. |