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.
To relocate the stent manufacturing line to another location within the same building
| Device | INCRAFT(R) AAA Stent Graft System |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Cordis Corporation |
| Date Received | 2019-07-22 |
| Decision Date | 2019-08-15 |
| PMA | P150002 |
| Supplement | S006 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis Corporation 6500 Paseo Padre Pkwy fremont, CA 94555 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150002 | Original Filing | |
| S010 | 2021-04-26 | 30-day Notice |
| S009 | ||
| S008 | 2020-03-31 | Normal 180 Day Track No User Fee |
| S007 | 2019-08-12 | 135 Review Track For 30-day Notice |
| S006 | 2019-07-22 | 30-day Notice |
| S005 | 2019-06-10 | 30-day Notice |
| S004 | 2019-05-24 | 30-day Notice |
| S003 | 2019-05-24 | 30-day Notice |
| S002 | 2019-05-01 | 30-day Notice |
| S001 | 2019-01-25 | Normal 180 Day Track No User Fee |