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 | S.M.A.R.T. RADIANZ Vascular Stent System |
| Generic Name | Stent, Iliac |
| Applicant | Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS045 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIO Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-02-25 |
| PMA | P020036 |
| Supplement | S045 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis US Corporation 14201 N.w. 60th Avenue miami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS045 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIO Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement for A New Delivery System To Allow Use With A Transradial Approach. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020036 | Original Filing | |
| S048 | 2022-11-21 | 30-day Notice |
| S047 | 2022-11-07 | 30-day Notice |
| S046 | ||
| S045 | 2021-09-01 | Normal 180 Day Track |
| S044 | 2021-03-03 | 30-day Notice |
| S043 | 2020-09-25 | 30-day Notice |
| S042 | 2020-05-01 | 30-day Notice |
| S041 | 2019-05-24 | 30-day Notice |
| S040 | 2019-04-01 | 30-day Notice |
| S039 | 2018-12-03 | 30-day Notice |
| S038 | 2018-02-26 | 30-day Notice |
| S037 | 2016-05-02 | Real-time Process |
| S036 | 2016-03-21 | 30-day Notice |
| S035 | 2015-10-05 | 30-day Notice |
| S034 | 2015-05-01 | 30-day Notice |
| S033 | 2015-03-19 | 135 Review Track For 30-day Notice |
| S032 | 2015-03-18 | 30-day Notice |
| S031 | 2014-12-19 | Normal 180 Day Track No User Fee |
| S030 | 2014-09-23 | 30-day Notice |
| S029 | 2014-05-12 | 30-day Notice |
| S028 | 2014-04-16 | 30-day Notice |
| S027 | ||
| S026 | 2014-03-24 | 30-day Notice |
| S025 | 2012-04-24 | 30-day Notice |
| S024 | 2012-04-23 | 30-day Notice |
| S023 | 2012-02-23 | 30-day Notice |
| S022 | 2012-01-09 | 30-day Notice |
| S021 | 2011-02-08 | Real-time Process |
| S020 | 2010-08-09 | 135 Review Track For 30-day Notice |
| S019 | 2010-08-05 | 30-day Notice |
| S018 | 2010-07-29 | 30-day Notice |
| S017 | 2010-02-16 | 30-day Notice |
| S016 | 2010-03-30 | Real-time Process |
| S015 | 2009-06-03 | 30-day Notice |
| S014 | 2009-04-09 | 30-day Notice |
| S013 | 2009-03-26 | 30-day Notice |
| S012 | 2008-12-03 | Special (immediate Track) |
| S011 | 2008-09-29 | 30-day Notice |
| S010 | 2008-07-18 | Special (immediate Track) |
| S009 | 2007-11-02 | 30-day Notice |
| S008 | 2007-08-24 | Special (immediate Track) |
| S007 | ||
| S006 | 2006-10-12 | 30-day Notice |
| S005 | 2006-08-11 | 30-day Notice |
| S004 | 2006-06-19 | 30-day Notice |
| S003 | 2006-06-19 | 30-day Notice |
| S002 | 2003-11-24 | Real-time Process |
| S001 | 2003-10-29 | Normal 180 Day Track No User Fee |