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 the manufacturing materials for the processing aid, which is used to tack the support member sleeve in place while the sleeve is heat-shrunk over the entire assembly.
| Device | CORDIS PRECISE RX NITINOL STENT SYSTEM |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | CORDIS CORP. |
| Date Received | 2007-12-17 |
| Decision Date | 2008-01-16 |
| PMA | P030047 |
| Supplement | S010 |
| Product Code | NIM |
| 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 |
|---|---|---|
| P030047 | Original Filing | |
| S046 | 2022-11-21 | 30-day Notice |
| S045 | 2022-11-07 | 30-day Notice |
| S044 | 2022-04-18 | 30-day Notice |
| S043 | 2022-01-14 | Special (immediate Track) |
| S042 | 2021-03-03 | 30-day Notice |
| S041 | 2021-03-03 | Special (immediate Track) |
| S040 | 2020-05-01 | 30-day Notice |
| S039 | 2019-05-24 | 30-day Notice |
| S038 | 2019-04-01 | 30-day Notice |
| S037 | ||
| S036 | 2018-12-03 | 30-day Notice |
| S035 | 2018-02-26 | 30-day Notice |
| S034 | 2017-11-20 | 30-day Notice |
| S033 | 2016-11-01 | 30-day Notice |
| S032 | 2016-03-21 | 30-day Notice |
| S031 | 2015-05-01 | 30-day Notice |
| S030 | 2015-04-27 | 135 Review Track For 30-day Notice |
| S029 | 2015-03-19 | 135 Review Track For 30-day Notice |
| S028 | 2015-03-18 | 30-day Notice |
| S027 | 2014-09-23 | 30-day Notice |
| S026 | ||
| S025 | 2012-04-23 | 30-day Notice |
| S024 | 2012-02-23 | 30-day Notice |
| S023 | 2012-01-09 | 30-day Notice |
| S022 | 2010-08-05 | 30-day Notice |
| S021 | 2010-07-29 | 30-day Notice |
| S020 | 2010-02-16 | 30-day Notice |
| S019 | 2010-02-16 | Real-time Process |
| S018 | 2009-06-02 | 30-day Notice |
| S017 | 2009-03-26 | 30-day Notice |
| S016 | 2008-12-03 | Special (immediate Track) |
| S015 | 2008-09-29 | 30-day Notice |
| S014 | 2008-07-15 | 30-day Notice |
| S013 | 2008-03-10 | 30-day Notice |
| S012 | 2008-02-06 | 135 Review Track For 30-day Notice |
| S011 | 2008-02-05 | 135 Review Track For 30-day Notice |
| S010 | 2007-12-17 | 30-day Notice |
| S009 | 2007-11-21 | Normal 180 Day Track No User Fee |
| S008 | 2007-11-02 | 30-day Notice |
| S007 | 2007-10-09 | 30-day Notice |
| S006 | ||
| S005 | 2007-08-27 | Special (immediate Track) |
| S004 | 2007-05-31 | 30-day Notice |
| S003 | 2007-04-16 | Normal 180 Day Track |
| S002 | 2007-02-21 | 30-day Notice |
| S001 | 2006-09-27 | Normal 180 Day Track |