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 the addition of a contract sterilizer located at steris-isomedix services, in temecula, california.
| Device | AFX ENDOVASCULAR AAA SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | ENDOLOGIX, INC. |
| Date Received | 2013-12-17 |
| Decision Date | 2014-02-06 |
| PMA | P040002 |
| Supplement | S045 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ENDOLOGIX, INC. 11 Studebaker irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040002 | Original Filing | |
| S070 | 2022-03-15 | Normal 180 Day Track |
| S069 | ||
| S068 | 2021-05-19 | 30-day Notice |
| S067 | 2021-03-11 | 30-day Notice |
| S066 | 2020-07-06 | 30-day Notice |
| S065 | 2020-06-26 | Special (immediate Track) |
| S064 | ||
| S063 | 2019-07-19 | 30-day Notice |
| S062 | ||
| S061 | 2018-07-10 | Special (immediate Track) |
| S060 | 2018-04-02 | Real-time Process |
| S059 | 2017-04-07 | Special (immediate Track) |
| S058 | 2017-02-07 | 135 Review Track For 30-day Notice |
| S057 | 2015-11-02 | 30-day Notice |
| S056 | 2015-10-19 | 30-day Notice |
| S055 | 2015-07-28 | Real-time Process |
| S054 | 2015-05-19 | Special (immediate Track) |
| S053 | 2014-07-16 | Special (immediate Track) |
| S052 | 2014-06-12 | 30-day Notice |
| S051 | 2014-06-12 | 30-day Notice |
| S050 | 2014-06-12 | 30-day Notice |
| S049 | 2014-06-12 | Real-time Process |
| S048 | 2014-06-12 | Real-time Process |
| S047 | 2014-05-09 | Normal 180 Day Track No User Fee |
| S046 | 2014-01-06 | 135 Review Track For 30-day Notice |
| S045 | 2013-12-17 | Normal 180 Day Track No User Fee |
| S044 | 2013-11-12 | Real-time Process |
| S043 | 2013-07-12 | Real-time Process |
| S042 | 2013-07-05 | Real-time Process |
| S041 | 2013-05-02 | Real-time Process |
| S040 | 2012-11-08 | Real-time Process |
| S039 | 2012-07-05 | Normal 180 Day Track |
| S038 | 2012-07-05 | Real-time Process |
| S037 | 2012-03-13 | Real-time Process |
| S036 | 2012-01-17 | 30-day Notice |
| S035 | 2011-11-01 | Real-time Process |
| S034 | 2011-10-13 | 30-day Notice |
| S033 | 2011-08-29 | 30-day Notice |
| S032 | 2011-05-31 | 30-day Notice |
| S031 | 2010-12-16 | Normal 180 Day Track |
| S030 | 2010-11-26 | 30-day Notice |
| S029 | 2010-11-18 | Real-time Process |
| S028 | 2010-04-08 | 30-day Notice |
| S027 | 2010-03-25 | Real-time Process |
| S026 | 2010-02-05 | Normal 180 Day Track |
| S025 | 2009-09-01 | Normal 180 Day Track |
| S024 | 2009-06-09 | 135 Review Track For 30-day Notice |
| S023 | 2009-01-22 | Real-time Process |
| S022 | 2008-10-06 | Normal 180 Day Track |
| S021 | 2008-09-08 | Real-time Process |
| S020 | 2008-07-23 | 30-day Notice |
| S019 | 2008-07-01 | Normal 180 Day Track |
| S018 | 2008-04-22 | Normal 180 Day Track |
| S017 | 2008-04-11 | Real-time Process |
| S016 | ||
| S015 | 2008-02-29 | Real-time Process |
| S014 | 2007-12-26 | Real-time Process |
| S013 | 2007-12-26 | Normal 180 Day Track No User Fee |
| S012 | 2007-04-19 | 30-day Notice |
| S011 | 2007-03-16 | 30-day Notice |
| S010 | 2007-03-15 | 30-day Notice |
| S009 | 2007-02-28 | 30-day Notice |
| S008 | 2006-12-19 | 30-day Notice |
| S007 | 2006-09-29 | Real-time Process |
| S006 | ||
| S005 | 2006-03-20 | Real-time Process |
| S004 | 2006-02-21 | Real-time Process |
| S003 | 2006-01-10 | 30-day Notice |
| S002 | 2005-11-10 | Normal 180 Day Track No User Fee |
| S001 | 2004-12-03 | Normal 180 Day Track No User Fee |