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 the addition of the us zilver ptx post-approval study 2 (pas 2) results to the instructions for use
| Device | Zilver® PTX® Drug-Eluting Peripheral Stent |
| Generic Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Applicant | Cook Ireland, Ltd. |
| Date Received | 2021-08-11 |
| Decision Date | 2021-11-02 |
| PMA | P100022 |
| Supplement | S038 |
| Product Code | NIU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Cook Ireland, Ltd. o'halloran Road national Technology Park limerick |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100022 | Original Filing | |
| S040 | 2021-11-04 | Real-time Process |
| S039 | ||
| S038 | 2021-08-11 | Normal 180 Day Track No User Fee |
| S037 | 2020-11-20 | 30-day Notice |
| S036 | 2020-07-02 | 30-day Notice |
| S035 | 2020-04-16 | 30-day Notice |
| S034 | 2019-09-03 | Special (immediate Track) |
| S033 | ||
| S032 | 2018-12-26 | Real-time Process |
| S031 | 2018-10-11 | 30-day Notice |
| S030 | 2018-10-09 | Normal 180 Day Track No User Fee |
| S029 | 2018-08-09 | 30-day Notice |
| S028 | 2018-08-01 | 30-day Notice |
| S027 | 2018-05-29 | Normal 180 Day Track |
| S026 | 2017-10-30 | Normal 180 Day Track |
| S025 | 2017-06-01 | Real-time Process |
| S024 | 2017-03-13 | 30-day Notice |
| S023 | 2017-03-07 | 30-day Notice |
| S022 | 2017-03-03 | Real-time Process |
| S021 | 2016-11-18 | Special (immediate Track) |
| S020 | 2016-07-05 | Panel Track |
| S019 | ||
| S018 | 2016-06-02 | 30-day Notice |
| S017 | 2016-03-15 | 30-day Notice |
| S016 | 2015-07-24 | 135 Review Track For 30-day Notice |
| S015 | 2015-07-15 | Special (immediate Track) |
| S014 | 2015-06-18 | Normal 180 Day Track |
| S013 | 2015-03-17 | Normal 180 Day Track No User Fee |
| S012 | 2015-02-02 | 30-day Notice |
| S011 | 2014-11-12 | Normal 180 Day Track No User Fee |
| S010 | 2014-04-17 | Normal 180 Day Track No User Fee |
| S009 | 2013-09-20 | 30-day Notice |
| S008 | 2013-07-22 | Real-time Process |
| S007 | 2013-06-24 | 30-day Notice |
| S006 | 2013-06-19 | Special (immediate Track) |
| S005 | ||
| S004 | 2012-12-13 | Normal 180 Day Track No User Fee |
| S003 | 2012-12-13 | Normal 180 Day Track No User Fee |
| S002 | 2012-12-11 | Normal 180 Day Track |
| S001 | 2012-12-03 | Normal 180 Day Track |