Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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/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.
 
DeviceZenith Dissection Endovascular System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantWILLIAM COOK EUROPE APS
SANDET 6, DK-4632
BJAEVERSKOV 
PMA NumberP180001
Date Received01/02/2018
Decision Date12/31/2018
Product Code MIH 
Docket Number 19M-0028
Notice Date 01/25/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT01568320
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
-
-