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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 NamePOWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoluminal prosthesis
ApplicantENDOLOGIX, INC.
PMA NumberP040002
Supplement NumberS029
Date Received12/07/2010
Decision Date01/20/2011
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for consolidation of all inner core configurations for the 17fr intuitrak accessory delivery system. The device, as modified, will be marketed under the trade name powerlink stent graft system with intuitrak delivery system and is indicated for endovascular treatment in patients with abdominal aortic aneurysms.
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