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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameANCURE/AORTOILIAC ENDOGRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
ApplicantGUIDANT CARDIAC AND VASCULAR SURGERY
PMA NumberP990017
Supplement NumberS030
Date Received12/19/2001
Decision Date04/24/2002
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 02M-0298
Notice Date 07/02/2002
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ancure aortoiliac system. This device is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients whose anatomy does not allow the use of a tube or bifurcated device.
Approval Order Approval Order
-
-