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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePOWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS029
Date Received11/18/2010
Decision Date01/20/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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