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 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK |
| Classification Name | Suture, Nonabsorbable, Silk |
| Generic Name | Suture, Nonabsorbable, Silk |
| Applicant | DEKNATEL, INC. |
| Date Received | 1987-06-09 |
| Decision Date | 1988-07-14 |
| PMA | N84348 |
| Supplement | S002 |
| Product Code | GAP |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N84348 | Original Filing | |
| S006 | 1989-05-09 | Normal 180 Day Track |
| S005 | 1988-03-31 | Normal 180 Day Track |
| S004 | 1987-12-30 | Normal 180 Day Track |
| S003 | 1987-09-18 | Normal 180 Day Track |
| S002 | 1987-06-09 | Normal 180 Day Track |
| S001 | 1980-09-23 |