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.
Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p150002.
| Device | INCRAFT 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 | 2019-01-25 |
| Decision Date | 2019-03-26 |
| PMA | P150002 |
| Supplement | S001 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |