| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | OVATION ABDOMINAL STENT GRAFT SYSTEM |
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| Classification Name | system, endovascular graft, aortic aneurysm treatment |
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| Applicant | TRIVASCULAR INC |
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| PMA Number | P120006 |
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| Date Received | 04/11/2012 |
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| Decision Date | 10/05/2012 |
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| Product Code | |
| Docket Number | 12M-1110 |
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| Notice Date | 11/08/2012 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials |
NCT01092117
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the ovation abdominal stent graft system. This device is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair, including: 1) adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal proximal aortic neck: a) with a length of at least 7 mm proximal to the aneurysm; b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and c) with an aortic angle of <= 60 degrees if proximal neck is >= 10 mm and <=45 degrees if proximal neck is <10 mm. 3) adequate distal iliac landing zone: a) with a length of at least 10 mm; and with an inner wall diameter of no less than 8 mm and no greater than 20 mm. |
| Approval Order |
Approval Order
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 |
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