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 to move the 34mm accessories over to intuitrak delivery system line as well as making a stand alone version of the 34mm bifurcated body delivery sheath available.
| Device | POWERLINK SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | ENDOLOGIX, INC. |
| Date Received | 2009-01-22 |
| Decision Date | 2009-02-20 |
| PMA | P040002 |
| Supplement | S023 |
| 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 | 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 |