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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403-1774
PMA NumberP990020
Date Received04/12/1999
Decision Date09/28/1999
Withdrawal Date 12/20/2013
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 99M-4331
Notice Date 10/15/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
This device is indicated for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm, and a vessel diameter 10-20% smaller than labeled device diameter; 3) Morphology suitable for endovascular repair; and 4) One of the following: A diameter > 5cm; A diameter of 4-5cm and has increased in size by 0.5cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta.
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 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046