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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.
 
DeviceAORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantLombard Medical Limited
4 Trident Park
Didcot OX11
PMA NumberP110032
Supplement NumberS010
Date Received11/07/2014
Decision Date02/03/2015
Withdrawal Date 03/13/2018
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LINE EXTENSION THAT WOULD INCLUDE TWO LARGER SIZE STENT GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, 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 19 MM TO 33 MM. 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF > 15 MM. 4) INFRARENAL AORTIC NECK ANGULATIONS INCLUDING THOSE UP TO AND INCLUDING 90°. 5) COMMON ILIAC LANDING ZONE DIAMETERS WITH A RANGE OF 9MM TO 19MM. 6) DISTAL FIXATION LENGTH OF > 15 MM.
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