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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DevicePOWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
ENDOLOGIX, INC.
11 studebaker
irvine, CA 92618
PMA NumberP040002
Supplement NumberS018
Date Received04/22/2008
Decision Date10/08/2008
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for suprarenal versions of the powerlink bifurcated stent grafts and accessories.
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