This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | MICROVEL(R) WITH HEMASHIELD |
| 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 | 1984-06-28 |
| Decision Date | 1989-04-26 |
| Notice Date | 1989-06-06 |
| PMA | P840029 |
| Supplement | S |
| Product Code | DSY |
| Docket Number | 89M-0170 |
| Advisory Committee | Cardiovascular |
| 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 |