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 reducing the sample size for the following processes: 1) the fusing operation for all precise devices and the sealing operation for precise rx; and 2) the bonding process of the precise rx and precise pro rx support member/wire lumen subassembly.
| Device | CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | CORDIS CORP. |
| Date Received | 2008-02-05 |
| Decision Date | 2008-09-30 |
| PMA | P030047 |
| Supplement | S011 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 |