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 in manufacturing facility for the supplier of the slider assembly and handle and the introduction of a new molding machine.
| Device | CORDIS SMART CONTROL NITINOL STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | CORDIS CORP. |
| Date Received | 2014-04-16 |
| Decision Date | 2014-05-12 |
| PMA | P020036 |
| Supplement | S028 |
| 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 | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
| 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 |