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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINCRAFT(R) AAA STENT GRAFT SYSTEM
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Cordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP150002
Date Received01/15/2015
Decision Date11/27/2018
Product Code MIH 
Docket Number 18M-4580
Notice Date 12/06/2018
Advisory Committee Cardiovascular
Clinical Trials NCT01664078
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the endovascular treatment of patients with infrarenal abdominal aortic aneurysms with the following characteristics:1) Adequate, but complex iliac or femoral vessel morphology (e.g., high tortuosity index, heavily calcified, small diameter), that is compatible with vascular access techniques, devices or accessories;2) Proximal neck length >= 10 mm;3) Aortic neck diameters >=17 mm and <= 31 mm;4) Aortic neck suitable for suprarenal fixation;5) Infrarenal and suprarenal neck angulation <= 60°;6) Iliac fixation length >= 15 mm;7) Iliac diameters >= 7 mm and <= 22 mm; and 8) Minimum overall AAA treatment length (proximal landing location to distal landing location) >= 128 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S010 
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