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 for a change the hydrophilic coating of the introducer sheath.
| Device | ZENITH TX2 TAA ENDVASCULAR GRAFT |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | WILLIAM COOK EUROPE APS |
| Date Received | 2014-11-03 |
| Decision Date | 2018-10-10 |
| PMA | P070016 |
| Supplement | S009 |
| Product Code | MIH |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |