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 a change to the center tube of the delivery system.
Device | AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM |
Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | Lombard Medical Limited |
Date Received | 2015-06-12 |
Decision Date | 2015-09-01 |
PMA | P110032 |
Supplement | S011 |
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 |