This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the zenith tx2 thoracic taa endovascular graft with the h&lb one-shot introduction system. This device is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: 1) adequate iliac/femoral access compatible with the required introduction systems; and 2) non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm or ulcer: a) with a length of at least 25 mm; and b) with a diameter measured outer wall to outer wall of no greater than 38 mm and no less than 24 mm.
| Device | ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | WILLIAM COOK EUROPE APS |
| Date Received | 2007-07-02 |
| Decision Date | 2008-05-21 |
| Notice Date | 2008-05-27 |
| PMA | P070016 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 08M-0311 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |