• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
WILLIAM COOK EUROPE APS
sandet 6, dk-4632
bjaeverskov 
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 
-
-