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 | DEXON |
| Generic Name | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | DAVIS & GECK, INC. |
| Date Received | 1987-10-14 |
| Decision Date | 1987-11-30 |
| PMA | N16881 |
| Supplement | S011 |
| Product Code | GAM |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
|---|---|---|
| N16881 | Original Filing | |
| S011 | 1987-10-14 | Normal 180 Day Track |
| S010 | 1987-04-14 | Normal 180 Day Track |
| S009 | 1986-10-28 | Normal 180 Day Track |
| S008 | 1986-03-25 | |
| S007 | ||
| S006 | 1981-07-01 | |
| S005 | 1981-06-04 | |
| S004 | 1981-05-19 | |
| S003 | 1980-08-29 | |
| S002 | 1980-11-17 | |
| S001 | 1980-10-22 |