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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 FENESTRATED AAA ENDOVASCULAR GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK INCORPORATED
PMA NumberP020018
Supplement NumberS040
Date Received10/07/2011
Decision Date04/04/2012
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 12M-0371
Notice Date 04/17/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00875563
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the zenith fenestrated aaa endovascular graft (with the adjunctive zenith alignment stent). The zenith fenestrated aaa endovascular graft is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: 1) adequate iliac/femoral access compatible with required introduction systems; 2) nonaneurysmal infrarenal aortic segment (neck) proximal to the aneurysms with: a) length >= 4 mm and unsuitable for a non-fenestrated graft. B) diameter <= 31 mm and >= 19 mm. C) angle < 45 degrees relative to long axis of aneurysm. D) angle < 45 degrees relative to axis of suprarenal aorta. 3) ipsilateral iliac artery fixation site > 30 mm in length and between 9 - 21 mm in diameter; and contralateral iliac artery distal fixation site > 30 mm in length and between 7 - 21 mm in diameter. The zenith alignment stent is indicated for use as an adjunct to the zenith fenestrated aaa endovascular graft to secure positive alignment of fenestrations or scallops with the orifice of aortic branch vessels having diameters ranging from 3 to 8 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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