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 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES |
| Generic Name | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | DAVIS & GECK, INC. |
| Date Received | 1986-07-01 |
| Decision Date | 1986-09-30 |
| PMA | N83509 |
| Supplement | S008 |
| Product Code | GAS |
| 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 | DAVIS & GECK, INC. 1 Casper St. danbury, CT 06810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N83509 | Original Filing | |
| S011 | 1987-04-14 | Normal 180 Day Track |
| S010 | 1986-12-05 | Normal 180 Day Track |
| S009 | 1986-10-02 | Normal 180 Day Track |
| S008 | 1986-07-01 | Normal 180 Day Track |
| S007 | 1982-12-29 | |
| S006 | 1982-06-17 | |
| S005 | 1982-06-17 | |
| S004 | 1981-12-15 | |
| S003 | ||
| S002 | 1980-12-16 | |
| S001 | 1980-02-01 |