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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 NameZENITH FLEX AAA ENDOVASCULAR GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK INCORPORATED
PMA NumberP020018
Supplement NumberS037
Date Received08/30/2010
Decision Date06/07/2011
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the zenith spiral-z aaa endovascular graft iliac leg to the existing zenith flex aaa endovascular graft product line. The device, as modified, will be marketed under the trade name zenith spiral-z aaa endovascular graft iliac leg and is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, or zenith branch iliac endovascular graft, during either a primary or secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems. The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.
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