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 | DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE |
| Generic Name | Tissue Graft Of 6mm And Greater |
| Applicant | SYNOVIS SURGICAL INNOVATIONS |
| Date Received | 1990-01-24 |
| Decision Date | 1990-09-11 |
| PMA | P780002 |
| Supplement | S008 |
| Product Code | LXA |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |