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.
| Device | GUT |
| Generic Name | Suture, Absorbable, Natural |
| Applicant | DEKNATEL, INC. |
| Date Received | 1981-04-08 |
| Decision Date | 1981-08-11 |
| PMA | N84381 |
| Supplement | S002 |
| Product Code | GAL |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N84381 | Original Filing | |
| S008 | 1988-03-31 | Normal 180 Day Track |
| S007 | 1987-12-30 | Normal 180 Day Track |
| S006 | 1987-09-18 | Normal 180 Day Track |
| S005 | 1984-06-21 | |
| S004 | 1984-05-09 | |
| S003 | 1983-04-14 | |
| S002 | 1981-04-08 | |
| S001 | 1981-02-05 |