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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 NameAFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoluminal prosthesis
ApplicantENDOLOGIX, INC.
PMA NumberP040002
Supplement NumberS038
Date Received07/05/2012
Decision Date08/22/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for stand-alone delivery system for the straight and tapered limb extension stent grafts and for the flared limb extensions grafts. The device, as modified, will be marketed under the trade name afx stand-alone limb extension delivery system as an accessory to the afx aaa endovascular system which is indicated for endovascular treatment in patients with aaa.
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