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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.
 
DeviceENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS004
Date Received02/21/2006
Decision Date04/14/2006
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR TWO NEW BIFURCATED BODY SIZES LISTED AS MODELS 25-16-120BL AND 28-16-120BL.
Post-Approval StudyShow Report Schedule and Study Progress
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