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 a manufacturing site located at cook ireland, ltd. , limerick, ireland for manufacturing and final manufacturing to include labeling and packaging, and for a sterilization site located at isotron ireland, ltd. , tullamore, ireland.
| Device | ZILVER VASCULAR STENT |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Cook Incorporated |
| Date Received | 2008-03-10 |
| Decision Date | 2009-02-03 |
| PMA | P050017 |
| Supplement | S002 |
| Product Code | NIO |
| 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 | Cook Incorporated p.o.box 489 bloomington, IN 47402 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050017 | Original Filing | |
| S019 | 2022-03-07 | 30-day Notice |
| S018 | 2020-01-08 | 30-day Notice |
| S017 | 2019-02-19 | 30-day Notice |
| S016 | 2018-05-30 | 30-day Notice |
| S015 | 2017-03-07 | 30-day Notice |
| S014 | 2016-11-18 | Special (immediate Track) |
| S013 | 2016-06-02 | 30-day Notice |
| S012 | 2015-08-05 | 30-day Notice |
| S011 | 2015-07-15 | Special (immediate Track) |
| S010 | 2014-07-15 | 30-day Notice |
| S009 | 2014-04-17 | Normal 180 Day Track No User Fee |
| S008 | 2013-07-25 | 30-day Notice |
| S007 | ||
| S006 | 2011-04-04 | Normal 180 Day Track |
| S005 | 2010-02-19 | Real-time Process |
| S004 | 2008-08-20 | Normal 180 Day Track |
| S003 | 2008-07-10 | Normal 180 Day Track No User Fee |
| S002 | 2008-03-10 | Normal 180 Day Track No User Fee |
| S001 | 2007-10-11 | 30-day Notice |