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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
11 studebaker
irvine, CA 92618
PMA NumberP040002
Date Received01/08/2004
Decision Date10/29/2004
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 04M-0533
Notice Date 12/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the endologix powerlink system. The powerlink system bifurcated models and proximal cuff and limb extension accessories are indicated for endovascular treatment in patients with aaa. The endologix powerlink system is indicated for patients with suitable aneurysm morphology for endovascular repair, including: 1) adequate iliac/femoral access compatible with the required delivery systems (a diameter of >= 7 mm). 2) non-aneurysmal aortic neck between the renal arteries and the aneurysm. 3) aortic length >= 1. 0 cm longer than the body portion of the chosen bifurcated model. 4) common iliac artery distal fixation site.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 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 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056