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 changes to the instructions for use (ifu) labeling. The labeling changes involved recommendations to users regarding maintaining hemostasis, use of fluoroscopy and trigger wire release, and an alternative suprarenal deployment sequence.
| Device | ZENITH AAA ENDOVASCULAR GRAFT |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | COOK, INC. |
| Date Received | 2012-01-10 |
| Decision Date | 2012-04-13 |
| PMA | P020018 |
| Supplement | S042 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |