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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceENDURANT II AUI STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS021
Date Received10/11/2012
Decision Date04/16/2013
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT00705718
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM, A LINE EXTENSION TO THE CURRENT ENDURANT II STENT GRAFT SYSTEM. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME ENDURANT II STENT GRAFT SYSTEM. THE ENDURANT II BIFURCATED STENTGRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS. THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT IS INDICATED FOR THE ENDOVASCULARTREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF A BIFURCATED STENT GRAFT. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; 2) PROXIMAL NECK LENGTH OF ¿ 10MM; 3)INFRARENAL NECK ANGULATION OF ¿ 60°; 4) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32MM; 5) DISTAL FIXATION LENGTH(S) OF ¿ 15 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25MM; AND 7) MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.
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