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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.
 
DeviceEndurant II/IIs Stent Graft System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS063
Date Received04/03/2017
Decision Date09/29/2017
Product Code MIH 
Docket Number 17M-5997
Notice Date 10/05/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01534819
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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