This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for modifications to procedures used for the manufacture and testing of the device. 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.
| Device | ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL |
| Classification Name | Inhibitor, Peridural Fibrosis (adhesion Barrier) |
| Generic Name | Inhibitor, Peridural Fibrosis (adhesion Barrier) |
| Applicant | WRIGHTMEDICALTECHNOLOGYINC |
| Date Received | 2000-06-26 |
| Decision Date | 2000-09-27 |
| PMA | P960057 |
| Supplement | S011 |
| Product Code | MLQ |
| Advisory Committee | Physical Medicine |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| 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 |