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 | VASCUTEK GELSOFT(TM) VASCULAR GRAFT |
| Generic Name | Graft, Vascular, Synthetic/biologic Composite |
| Applicant | CARBOMEDICS, INC. |
| Date Received | 1993-11-05 |
| Decision Date | 1993-12-07 |
| PMA | P890045 |
| Supplement | S003 |
| Product Code | MAL |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARBOMEDICS, INC. 1300-d East Anderson Ln. austin, TX 78752 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890045 | Original Filing | |
| S006 | 1994-04-18 | Normal 180 Day Track |
| S005 | 1994-03-31 | Normal 180 Day Track |
| S004 | ||
| S003 | 1993-11-05 | Normal 180 Day Track |
| S002 | ||
| S001 | 1993-07-08 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 05037881110585 | P890045 | 000 |
| 05037881101194 | P890045 | 000 |