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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 STENT GRAFT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoluminal prosthesis
ApplicantENDOLOGIX, INC.
PMA NumberP040002
Supplement NumberS004
Date Received02/23/2006
Decision Date04/14/2006
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
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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