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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePOWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoluminal prosthesis
ApplicantENDOLOGIX, INC.
PMA NumberP040002
Supplement NumberS009
Date Received02/28/2007
Decision Date03/29/2007
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to the surepass contralateral limb sheath/guidewire assembly of the visiflex delivery system.
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