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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.
 
Trade NameENDOLOGIX POWERLINK SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantENDOLOGIX, INC.
PMA NumberP040002
Supplement NumberS005
Date Received03/20/2006
Decision Date05/17/2006
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a new version of the visiflex delivery catheter for both the bifurcated and straight stent grafts.
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