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 | MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE |
| Generic Name | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | DAVIS & GECK, INC. |
| Date Received | 1995-12-19 |
| Decision Date | 1996-01-11 |
| PMA | P840051 |
| Supplement | S007 |
| Product Code | GAM |
| 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. 1 Casper St. danbury, CT 06810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840051 | Original Filing | |
| S008 | 1996-10-30 | Real-time Process |
| S007 | 1995-12-19 | Special (immediate Track) |
| S006 | 1991-10-02 | Normal 180 Day Track |
| S005 | 1991-08-07 | Normal 180 Day Track |
| S004 | 1991-02-20 | Normal 180 Day Track |
| S003 | 1989-05-15 | Normal 180 Day Track |
| S002 | ||
| S001 | 1987-04-14 | Normal 180 Day Track |