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.
The 30-day notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the adcon(r)-l adhesion control barrier gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.
| Device | ADCON -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 | 1998-12-21 |
| Decision Date | 1999-01-14 |
| PMA | P960057 |
| Supplement | S003 |
| Product Code | MLQ |
| Advisory Committee | Physical Medicine |
| Supplement Type | 30-day Notice |
| 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 |