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.
Approval for a revision of the existing package inserts, under the provisions of 814. 39(d)(1), special pma supplement-changes being effected
| Device | NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE |
| Generic Name | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | DAVIS & GECK, INC. |
| Date Received | 1995-12-19 |
| Decision Date | 1996-01-11 |
| PMA | P840041 |
| Supplement | S006 |
| Product Code | GAS |
| 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. one Casper St. danbury, CT 06810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840041 | Original Filing | |
| S006 | 1995-12-19 | Special (immediate Track) |
| S005 | 1993-10-04 | Normal 180 Day Track |
| S004 | 1989-06-09 | Normal 180 Day Track |
| S003 | 1988-03-21 | Normal 180 Day Track |
| S002 | 1987-04-14 | Normal 180 Day Track |
| S001 | 1986-11-04 | Normal 180 Day Track |