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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.
 
DeviceAFX ENDOVASCULAR AAA SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
ENDOLOGIX, INC.
11 studebaker
irvine, CA 92618
PMA NumberP040002
Supplement NumberS041
Date Received05/02/2013
Decision Date06/17/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a release sleeve to the proximal extension accessory stent graft delivery system. The device, as modified, will be marketed under the trade name afx vela proximal endograft system.
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