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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantWILLIAM COOK EUROPE APS
PMA NumberP070016
Date Received07/02/2007
Decision Date05/21/2008
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 08M-0311
Notice Date 05/27/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 
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