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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
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: S033 S034  S045 S046 S040 S001 S041 S056 S057 S044 S042 
S053 S047 S054 S038 S039 S037 S023 S013 S014 S004 S005 S012 
S019 S020 S003 S029 S030 S031 S059 S032 S035 S055 S051 S052 
S048 S049 S050 S036 S043 S007 S024 S025 S026 S021 S022 S015 
S017 S027 S028 S008 S009 S010 S011 S002 S018 S058 S061 S067 
S060 S065 S062 S063 S066 S071 S068 S070 
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