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 following change to the deliver system of the s. M. A. R. T. Control nitinol stent system: 1) the wire lumen of the delivery system will be fabricated from different materials. 2) the new wire lumen inner diameter specification has been increased. 3) the proximal land section of the distal tip has been increased. 4) the inner diameter specification of the distal tip has been increase.
| Device | SMART CONTROL NITINOL STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | CORDIS CORP. |
| Date Received | 2003-11-24 |
| Decision Date | 2004-03-19 |
| PMA | P020036 |
| Supplement | S002 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |