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.
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.
| Device | ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL |
| Classification Name | Inhibitor, Peridural Fibrosis (adhesion Barrier) |
| Generic Name | Inhibitor, Peridural Fibrosis (adhesion Barrier) |
| Applicant | WRIGHTMEDICALTECHNOLOGYINC |
| Date Received | 1996-12-23 |
| Decision Date | 1998-05-27 |
| Notice Date | 1998-06-23 |
| PMA | P960057 |
| Supplement | S |
| Product Code | MLQ |
| Docket Number | 98M-0404 |
| Advisory Committee | Neurology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | WRIGHTMEDICALTECHNOLOGYINC 5677 Airline Rd. arlinton, TN 38002 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960057 | Original Filing | |
| S011 | 2000-06-26 | Special (immediate Track) |
| S010 | ||
| S009 | ||
| S008 | 1999-05-13 | Special (immediate Track) |
| S007 | ||
| S006 | 1999-03-12 | Real-time Process |
| S005 | 1999-02-19 | 135 Review Track For 30-day Notice |
| S004 | 1999-02-11 | Normal 180 Day Track |
| S003 | 1998-12-21 | 30-day Notice |
| S002 | 1998-11-03 | Real-time Process |
| S001 | 1998-08-28 | 30-day Notice |