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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.
 
DeviceENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM
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 NumberS004
Date Received02/21/2006
Decision Date04/14/2006
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 two new bifurcated body sizes listed as models 25-16-120bl and 28-16-120bl.
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