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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 STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS011
Date Received11/02/2011
Decision Date04/27/2012
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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