| 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. |
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| Device | INCRAFT(R) AAA STENT GRAFT SYSTEM |
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| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
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| Applicant | Cordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014 |
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| PMA Number | P150002 |
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| Date Received | 01/15/2015 |
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| Decision Date | 11/27/2018 |
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| Product Code |
MIH |
| Docket Number | 18M-4580 |
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| Notice Date | 12/06/2018 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01664078
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S010 |
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