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 add the zenith spiral-z aaa endovascular graft iliac leg to the existing zenith flex aaa endovascular graft product line. The device, as modified, will be marketed under the trade name zenith spiral-z aaa endovascular graft iliac leg and is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, or zenith branch iliac endovascular graft, during either a primary or secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems. The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.
| Device | ZENITH FLEX AAA ENDOVASCULAR GRAFT |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | COOK, INC. |
| Date Received | 2010-08-30 |
| Decision Date | 2011-06-07 |
| PMA | P020018 |
| Supplement | S037 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOK, INC. 750 Daniels Way p.o. Box 489 bloomington, IN 47402 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020018 | Original Filing | |
| S060 | 2021-07-23 | Normal 180 Day Track No User Fee |
| S059 | 2020-09-17 | Special (immediate Track) |
| S058 | 2018-06-22 | Special (immediate Track) |
| S057 | 2016-11-09 | Special (immediate Track) |
| S056 | 2016-05-04 | Special (immediate Track) |
| S055 | 2014-11-03 | Real-time Process |
| S054 | ||
| S053 | 2014-09-22 | 30-day Notice |
| S052 | 2014-05-06 | Special (immediate Track) |
| S051 | ||
| S050 | 2014-02-11 | Normal 180 Day Track No User Fee |
| S049 | 2013-03-26 | Special (immediate Track) |
| S048 | 2013-03-18 | Normal 180 Day Track No User Fee |
| S047 | 2012-11-13 | 30-day Notice |
| S046 | 2012-07-26 | Normal 180 Day Track |
| S045 | 2012-06-28 | Special (immediate Track) |
| S044 | 2012-05-04 | Normal 180 Day Track No User Fee |
| S043 | 2012-05-04 | Normal 180 Day Track No User Fee |
| S042 | 2012-01-10 | Normal 180 Day Track |
| S041 | 2011-10-11 | Normal 180 Day Track |
| S040 | 2011-10-07 | Panel Track |
| S039 | 2011-06-23 | Normal 180 Day Track No User Fee |
| S038 | 2011-05-03 | 30-day Notice |
| S037 | 2010-08-30 | Normal 180 Day Track |
| S036 | 2010-06-18 | 30-day Notice |
| S035 | ||
| S034 | 2010-03-10 | Special (immediate Track) |
| S033 | 2009-06-04 | Real-time Process |
| S032 | 2009-02-23 | Normal 180 Day Track |
| S031 | 2009-02-02 | Special (immediate Track) |
| S030 | 2008-11-24 | 30-day Notice |
| S029 | 2008-08-15 | 135 Review Track For 30-day Notice |
| S028 | ||
| S027 | 2008-05-09 | Special (immediate Track) |
| S026 | 2008-03-03 | Normal 180 Day Track |
| S025 | 2008-01-22 | 135 Review Track For 30-day Notice |
| S024 | 2007-05-01 | Normal 180 Day Track |
| S023 | 2007-02-21 | Normal 180 Day Track No User Fee |
| S022 | 2006-11-13 | 135 Review Track For 30-day Notice |
| S021 | 2006-11-06 | 30-day Notice |
| S020 | 2006-11-06 | 30-day Notice |
| S019 | 2006-11-06 | 30-day Notice |
| S018 | 2006-10-05 | 30-day Notice |
| S017 | 2006-10-04 | 30-day Notice |
| S016 | 2006-09-18 | 135 Review Track For 30-day Notice |
| S015 | 2006-09-18 | 30-day Notice |
| S014 | 2006-09-18 | 30-day Notice |
| S013 | 2006-09-18 | 30-day Notice |
| S012 | ||
| S011 | 2006-09-18 | 135 Review Track For 30-day Notice |
| S010 | 2006-06-02 | Normal 180 Day Track |
| S009 | 2006-05-01 | Special (immediate Track) |
| S008 | 2006-01-09 | Special (immediate Track) |
| S007 | 2005-10-17 | Normal 180 Day Track No User Fee |
| S006 | 2005-05-19 | 30-day Notice |
| S005 | 2005-01-03 | Normal 180 Day Track |
| S004 | 2004-05-11 | Normal 180 Day Track |
| S003 | 2003-12-22 | Normal 180 Day Track |
| S002 | 2003-10-06 | Normal 180 Day Track |
| S001 | 2003-09-22 | Normal 180 Day Track No User Fee |