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Device | ENDURANT II STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S011 |
Date Received | 11/02/2011 |
Decision Date | 04/27/2012 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFIED VERSION OF THE ENDURANT STENT GRAFT SYSTEM. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING ADEQUATE ILIAC/FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; PROXIMAL NECK LENGTH OF => 10 MM: INFRARENAL NECK ANGULATION OF =< 60°; DISTAL FIXATION LENGTH OF => 15 MM; AORTIC NECK DIAMETERS WITH A RANGE OF 19-32 MM; ILIAC DIAMETERS WITH A RANGE OF 8-25 MM AND MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR. |