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 | DARDIK BIOGRAFT |
| Generic Name | Tissue Graft Of 6mm And Greater |
| Applicant | SYNOVIS SURGICAL INNOVATIONS |
| Date Received | 1978-06-12 |
| Decision Date | 1979-01-17 |
| Notice Date | 1979-07-24 |
| PMA | P780002 |
| Supplement | S |
| Product Code | LXA |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SYNOVIS SURGICAL INNOVATIONS 2575 University Ave. West st. Paul, MN 55114-1024 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P780002 | Original Filing | |
| S012 | 1995-09-08 | Normal 180 Day Track |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 1990-01-24 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 1984-03-12 | |
| S004 | 1981-11-12 | |
| S003 | ||
| S002 | 1980-07-31 | Normal 180 Day Track |
| S001 | 1981-03-12 |