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.
Change to the coating process parameters for the release-wires.
| Device | ZENITH TX2 TAA ENDOVASCULAR GRAFT |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | WILLIAM COOK EUROPE APS |
| Date Received | 2015-07-06 |
| Decision Date | 2015-08-03 |
| PMA | P070016 |
| Supplement | S010 |
| 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 | WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070016 | Original Filing | |
| S010 | 2015-07-06 | 30-day Notice |
| S009 | 2014-11-03 | Real-time Process |
| S008 | ||
| S007 | 2013-04-23 | Special (immediate Track) |
| S006 | 2011-07-19 | Normal 180 Day Track No User Fee |
| S005 | 2011-07-12 | 135 Review Track For 30-day Notice |
| S004 | 2009-04-06 | Normal 180 Day Track |
| S003 | 2008-09-05 | 135 Review Track For 30-day Notice |
| S002 | 2008-08-15 | Normal 180 Day Track |
| S001 | 2008-06-02 | Normal 180 Day Track No User Fee |