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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAORFIX FLEXIBLE STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantLombard Medical Limited
4 Trident Park
Didcot OX11
PMA NumberP110032
Date Received08/15/2011
Decision Date02/14/2013
Withdrawal Date 03/13/2018
Product Code MIH 
Docket Number 13M-0282
Notice Date 03/13/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00522535
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULARREPAIR, INCLUDING:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES; 2) AORTIC NECK LANDING ZONE DIAMETERS WITH A RANGE OF 19MM TO 29MM; 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF >= L5MM; 4) LNFRARENAL AORTIC NECK ANGULATIONS INCLUDING THOSE UP TO AND INCLUDING 90°; 5) COMMON ILIAC LANDING ZONE DIAMETERS WITH A RANGE OF 9MM TO 19MM; AND 6) DISTAL FIXATION LENGTH OF >= 15MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S006 S009 S010 S011 S013 
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