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.
Change the manufacturing process of flaring the polyethylene reinforced sleeves from a manual process to an automated process.
| Device | ZILVER VASCULAR STENT |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Cook Incorporated |
| Date Received | 2013-07-25 |
| Decision Date | 2013-08-22 |
| PMA | P050017 |
| Supplement | S008 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |