• 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
 
DeviceZenith Dissection Endovascular 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 NumberP180001
Date Received01/02/2018
Decision Date12/31/2018
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 19M-0028
Notice Date 01/25/2019
Advisory Committee Cardiovascular
Clinical Trials NCT01568320
NCT02094300
NCT02464943
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the endovascular treatment of patients with Type B aortic dissection. The Zenith TX2 Dissection Endovascular Graft with Pro-Form is intended to seal the entry tear(s) and to exclude aneurysms associated with chronic dissections. The Zenith Dissection Endovascular Stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a Zenith TX2 Dissection Endovascular Graft with Pro-Form. The system is indicated for use in patients having suitable vascular anatomy for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems; for the Zenith TX2 Dissection Endovascular Graft with Pro-Form: non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm for the graft, and non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm for the graft; for the Zenith Dissection Endovascular Stent: diameter at non-aneurysmal intended implant site for the stent (measured outer-wall to outer- wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-