| 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. |
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| Device | ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM |
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| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
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| Applicant | Medtronic Vascular
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774 |
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| PMA Number | P990020 |
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| Supplement Number | S020 |
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| Date Received | 06/24/2005 |
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| Decision Date | 03/17/2006 |
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Withdrawal Date
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12/20/2013 |
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| Product Code |
MIH |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR ADDITIONAL ILIAC SIZES (INCLUDING 18MM AND 20MM DIAMETERS; FLARED ILIAC AND ILIAC CUFFS IN 16 MM X 20MM, 18MM X 22MM, AND 18MM X 24MM); A LONGER AORTIC BODY OF THE BIFURCATED COMPONENT BY 1 CM; PRE-SHAPED (CONTOURED) STENT RINGS; AND PLATINUM-IRIDIUM RADIOPAQUE MARKETS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING: 1) ADEQUATE ILIAC/FEMORAL ACCESS; 2) INFRARENAL, NON-ANEURYSMAL, NECK LENGTH OF GREATER THAN 1 CM AT THE PROXIMAL AND DISTAL ENDS OF THE ANEURYSM AND AN INNER VESSEL DIAMETER APPROXIMATELY 10-20% SMALLER THAN THE LABELED DEVICE DIAMETER; 3) MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR; 4) ONE OF THE FOLLOWING: ANEURYSM DIAMETER > 5 CM; ANEURYSM DIAMETER OF 4-5 CM WHICH HAS ALSO INCREASED IN SIZE BY 0.5 CM IN THE LAST 6 MONTHS; OR ANEURYSM WHICH IS TWICE THE DIAMETER OF THE NORMAL INFRARENAL AORTA. |
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