This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the cordis precise nitinol stent system (5. 5 fr and 6. 0 fr sizes, over-the-wire configuration). This device is indicated for use in conjunction with the angioguard xp emboli capture guidewire for the treatment of patients at high risk for adverse events from carotid endarterectomy (defined in the ifu) who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >=50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by ultrasound or angiogram, and 2) patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7. 5mm to allow for placement of the angioguard xp emboli capture guidewire.
| Device | CORDIS PRECISE NITINOL STENT SYSTEM |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | CORDIS CORP. |
| Date Received | 2003-10-08 |
| Decision Date | 2006-09-22 |
| Notice Date | 2006-10-17 |
| PMA | P030047 |
| Supplement | S |
| Product Code | NIM |
| Docket Number | 06M-0412 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |