Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


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