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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 WITH INTUITRAK DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS032
Date Received05/31/2011
Decision Date06/30/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
ALTERNATE SUPPLIER OF SUTURE MATERIAL.
Post-Approval StudyShow Report Schedule and Study Progress
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