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 | DEKLENE(TM) |
| Classification Name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Generic Name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | DEKNATEL, INC. |
| Date Received | 1988-12-20 |
| Decision Date | 1989-02-02 |
| PMA | P810028 |
| Supplement | S010 |
| Product Code | GAT |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810028 | Original Filing | |
| S011 | 1989-05-09 | Normal 180 Day Track |
| S010 | 1988-12-20 | Normal 180 Day Track |
| S009 | 1988-03-31 | Normal 180 Day Track |
| S008 | 1987-12-30 | Normal 180 Day Track |
| S007 | 1987-09-18 | Normal 180 Day Track |
| S006 | 1987-06-09 | Normal 180 Day Track |
| S005 | 1984-09-07 | |
| S004 | 1984-06-21 | |
| S003 | 1983-06-15 | |
| S002 | 1983-05-26 | |
| S001 | 1983-04-26 |