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 | HEMASHIELD ETS(TM) FLANGED GRAFT |
| Classification Name | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Generic Name | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MAQUET CARDIOVASCULAR, LLC |
| Date Received | 1990-10-24 |
| Decision Date | 1993-05-17 |
| PMA | P840029 |
| Supplement | S004 |
| Product Code | DSY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MAQUET CARDIOVASCULAR, LLC 45 Barbour Pond Drive wayne, NJ 07470 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840029 | Original Filing | |
| S015 | 1992-04-22 | Normal 180 Day Track |
| S014 | 1992-04-22 | Normal 180 Day Track |
| S013 | ||
| S012 | ||
| S011 | 1992-02-04 | Normal 180 Day Track |
| S010 | 1992-02-04 | Normal 180 Day Track |
| S009 | 1992-01-21 | Normal 180 Day Track |
| S008 | 1992-01-06 | Normal 180 Day Track |
| S007 | 1991-11-08 | Normal 180 Day Track |
| S006 | 1991-11-08 | Normal 180 Day Track |
| S005 | 1991-04-19 | Normal 180 Day Track |
| S004 | 1990-10-24 | Normal 180 Day Track |
| S003 | ||
| S002 | 1990-01-09 | Normal 180 Day Track |
| S001 |