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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendoluminal prosthesis
PMA NumberP040002
Supplement NumberS035
Date Received11/01/2011
Decision Date12/06/2011
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified contralateral limb surepass guidewire holder. The device, as modified, will be marketed under the trade name afx aaa endovascular system and is indicated for endovascular treatment in patients with aaa.