This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the endologix powerlink system. The powerlink system bifurcated models and proximal cuff and limb extension accessories are indicated for endovascular treatment in patients with aaa. The endologix powerlink system is indicated for patients with suitable aneurysm morphology for endovascular repair, including: 1) adequate iliac/femoral access compatible with the required delivery systems (a diameter of >= 7 mm). 2) non-aneurysmal aortic neck between the renal arteries and the aneurysm. 3) aortic length >= 1. 0 cm longer than the body portion of the chosen bifurcated model. 4) common iliac artery distal fixation site.
| Device | ENDOLOGIX POWERLINK SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | ENDOLOGIX, INC. |
| Date Received | 2004-01-08 |
| Decision Date | 2004-10-29 |
| Notice Date | 2004-12-08 |
| PMA | P040002 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 04M-0533 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ENDOLOGIX, INC. 11 Studebaker irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |