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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameENDOLOGIX POWERLINK SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoluminal prosthesis
ApplicantENDOLOGIX, INC.
PMA NumberP040002
Date Received01/08/2004
Decision Date10/29/2004
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 04M-0533
Notice Date 12/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
-
-