• 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
3450 kiltie lane
p.o. box 2400
flagstaff, AZ 86003-2400
PMA NumberP040043
Supplement NumberS040
Date Received07/01/2011
Decision Date01/13/2012
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 12M-0056
Notice Date 01/19/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00917852
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the gore tag thoracic endoprosthesis. The device is intended for endovascular repair of isolated lesions (not including dissections) of the descending thoracic aorta, in patients who have appropriate anatomy including adequate iliac/femoral access, aortic inner diameter in the range of 16-42 mm, and >= 20 mm non-aneurysmal aorta proximal and distal to the lesion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling