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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceENDOLOGIX POWERLINK SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Date Received01/08/2004
Decision Date10/29/2004
Product Code MIH 
Docket Number 04M-0533
Notice Date 12/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ENDOLOGIX POWERLINK SYSTEM. THE POWERLINK SYSTEM BIFURCATED MODELS AND PROXIMAL CUFF AND LIMB EXTENSION ACCESSORIES ARE INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA. THE ENDOLOGIX POWERLINK SYSTEM IS INDICATED FOR PATIENTS WITH SUITABLE ANEURYSM MORPHOLOGY FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED DELIVERY SYSTEMS (A DIAMETER OF >= 7 MM). 2) NON-ANEURYSMAL AORTIC NECK BETWEEN THE RENAL ARTERIES AND THE ANEURYSM. 3) AORTIC LENGTH >= 1.0 CM LONGER THAN THE BODY PORTION OF THE CHOSEN BIFURCATED MODEL. 4) COMMON ILIAC ARTERY DISTAL FIXATION SITE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S032 S060 S062 S063 S065 S066  S002 S059 S017 S018 S021 
S022 S008 S009 S010 S011 S027 S028 S024 S061 S070 S071 S067 
S072 S073 S040 S053 S047 S054 S007 S001 S012 S019 S020 S003 
S004 S068 S033 S034 S035 S042 S055 S051 S052 S048 S049 S050 
S038 S039 S044 S036 S043 S030 S031 S013 S014 S015 S023 S025 
S026 S005 S058 S029 S041 S075 S037 S056 S057 S045 S046 
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