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 | SURGILENE |
| Generic Name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | DAVIS & GECK, INC. |
| Date Received | 1988-02-02 |
| Decision Date | 1988-03-01 |
| PMA | N17825 |
| Supplement | S016 |
| Product Code | GAT |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAVIS & GECK, INC. american Cynamid Company one Casper Street danbury, CT 06810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17825 | Original Filing | |
| S017 | 1988-05-03 | Normal 180 Day Track |
| S016 | 1988-02-02 | Special (immediate Track) |
| S015 | 1987-04-14 | Normal 180 Day Track |
| S014 | 1985-07-02 | |
| S013 | 1984-02-06 | |
| S012 | 1981-07-08 | |
| S011 | 1982-06-17 | |
| S010 | 1982-06-17 | |
| S009 | 1981-07-06 | |
| S008 | 1980-12-01 | |
| S007 | ||
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | ||
| S001 | 1980-11-24 |