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.
| Device | Zilver Vascular Stent |
| Generic Name | Stent, Iliac |
| Applicant | Cook Ireland, Ltd.o'halloran Roadnational Technology Parklimerick PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-04-04 |
| PMA | P050017 |
| Supplement | S019 |
| 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 Ireland, Ltd. o'halloran Road national Technology Park limerick PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Supplier Change For The Delivery System Tip Component |
| 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 |