PMA P110032S010
- Device
- AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S010
- Product code
- MIH
- Decision date
- 2015-02-03
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- 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.
Current openFDA PMA Record#
- Device
- AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S010
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-02-03
- Decision code
- APPR
- Date received
- 2014-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.