PMA P110032S002

Device: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
Applicant: Lombard Medical Limited
PMA number: P110032
Supplement: S002
Product code: MIH
Decision date: 2013-06-17
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR SEVERAL MODIFICATIONS TO THE OUTER SHEATH OF THE DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY SYSTEM 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 19MM TO 29MM; 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF 15MM; 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; AND 6) DISTAL FIXATION LENGTH OF 15MM.

Current openFDA PMA Record#

Device: AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
Applicant: Lombard Medical Limited
PMA number: P110032
Supplement: S002
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2013-06-17
Decision code: APPR
Date received: 2013-04-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SEVERAL MODIFICATIONS TO THE OUTER SHEATH OF THE DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY SYSTEM 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 19MM TO 29MM; 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF 15MM; 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; AND 6) DISTAL FIXATION LENGTH OF 15MM.