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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 SYSTEM WITH INTUITRAK DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS039
Date Received07/05/2012
Decision Date04/16/2013
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT01070069
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF BILATERAL PERCUTANEOUS ACCESS TO THE DEVICE LABELING.
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