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.
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.
Device | AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | Lombard Medical Limited |
Date Received | 2013-04-09 |
Decision Date | 2013-06-17 |
PMA | P110032 |
Supplement | S002 |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | Lombard Medical Limited 4 Trident Park didcot OX11 |
Supplement Number | Date | Supplement Type |
---|---|---|
P110032 | Original Filing | |
S013 | 2017-07-24 | Normal 180 Day Track No User Fee |
S012 | ||
S011 | 2015-06-12 | Real-time Process |
S010 | 2014-11-07 | Real-time Process |
S009 | 2014-10-01 | 30-day Notice |
S008 | ||
S007 | ||
S006 | 2013-10-22 | Special (immediate Track) |
S005 | 2013-06-21 | 30-day Notice |
S004 | ||
S003 | 2013-05-20 | 30-day Notice |
S002 | 2013-04-09 | Real-time Process |
S001 |