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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceZenith® Iliac Branch
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP020018
Supplement NumberS064
Date Received08/01/2024
Decision Date05/30/2025
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT01208415
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Zenith Iliac Branch. The Zenith Iliac Branch, when used with the necessary additional components (Zenith AAA devices and a covered bridging stent), is indicated for endovascular treatment of aortoiliac or iliac aneurysms to preserve internal iliac arterial blood flow when the distal sealing site in the common iliac artery is insufficient for the AAA device alone and when the vessel morphology is suitable for repair: 1) Common iliac artery diameter at the level of the internal iliac artery (luminal diameter) ?16 mm; 2) Adequate iliac/femoral access compatible with a 20 French (7.7mm O.D.) introduction system; 3) Non-aneurysmal external iliac artery fixation segment distal to the aneurysm: with a length of at least 20mm and with a diameter measured outer wall to outer wall of no greater than 11mm and no less than 8mm; 4) Non-aneurysmal internal iliac artery segment distal to the aneurysm: with a length of at least 10mm (with 20-30mm being preferred) and with a diameter measured outer wall to outer wall no greater than 10mm and no less than 7mm
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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