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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.
 
DeviceEdurant II/IIs Stent Graft System
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP100021
Supplement NumberS063
Date Received04/03/2017
Decision Date09/29/2017
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 17M-5997
Notice Date 10/05/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01534819
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the expansion of the indications for use of the Endurant II/Endurant IIs Stent Graft System to include the treatment of infrarenal abdominal aortic aneurysms having neck lengths >= 4 mm and < 10 mm (“short necks”), when used in conjunction with the Heli-FX EndoAnchor System. The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (>= 4 mm and < 10 mm) infrarenal necks. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/Endurant IIs Stent Graft System is indicated for use in patients with the following characteristics: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) Proximal neck length of: >=10 mm or >= 4 and <10 mm, when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only) (Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter); 3) Infrarenal neck angulation of <= 60°; 4) Aortic neck diameters with a range of 19 to 32 mm; 5) Distal fixation length(s) of >= 15 mm; 6) Iliac diameters with a range of 8 to 25 mm; and 7) Morphology suitable for aneurysm repair.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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