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 modifications of the device labeling to include an additional warning and a summary of the capture post-approval study. The device, as modified, will be marketed under the trade name rx accuylink carotid stent system and, used in conjunction with abbott vascular x accunet embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require revascularization and meet the following criteria: 1) patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients with out neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and 2) patients must have a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion.
| Device | RX ACCULINK CAROTID STENT SYSTEM |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2007-09-27 |
| Decision Date | 2008-02-21 |
| PMA | P040012 |
| Supplement | S027 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040012 | Original Filing | |
| S064 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S063 | 2021-11-09 | 30-day Notice |
| S062 | 2021-09-20 | 30-day Notice |
| S061 | 2021-05-18 | 30-day Notice |
| S060 | 2020-09-08 | 30-day Notice |
| S059 | 2017-03-21 | 30-day Notice |
| S058 | 2016-10-03 | Real-time Process |
| S057 | 2016-09-26 | Normal 180 Day Track No User Fee |
| S056 | 2016-01-04 | Normal 180 Day Track No User Fee |
| S055 | 2015-03-09 | 30-day Notice |
| S054 | 2015-01-14 | 30-day Notice |
| S053 | 2013-11-29 | 135 Review Track For 30-day Notice |
| S052 | 2013-07-29 | 30-day Notice |
| S051 | 2012-12-19 | 30-day Notice |
| S050 | 2012-10-31 | Real-time Process |
| S049 | 2012-08-24 | 30-day Notice |
| S048 | 2012-06-13 | 30-day Notice |
| S047 | 2012-06-11 | 30-day Notice |
| S046 | 2012-06-06 | Normal 180 Day Track No User Fee |
| S045 | 2012-05-24 | 30-day Notice |
| S044 | 2012-03-20 | Normal 180 Day Track |
| S043 | 2011-11-21 | 30-day Notice |
| S042 | 2011-09-19 | Normal 180 Day Track |
| S041 | 2011-08-02 | 30-day Notice |
| S040 | 2011-06-10 | 30-day Notice |
| S039 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S038 | 2011-02-28 | 30-day Notice |
| S037 | 2011-02-28 | 30-day Notice |
| S036 | 2011-02-18 | 135 Review Track For 30-day Notice |
| S035 | 2010-10-05 | 30-day Notice |
| S034 | 2010-10-01 | Panel Track |
| S033 | 2010-09-17 | 30-day Notice |
| S032 | 2010-05-03 | 135 Review Track For 30-day Notice |
| S031 | 2009-11-02 | Normal 180 Day Track |
| S030 | 2009-07-06 | 30-day Notice |
| S029 | 2008-12-22 | 30-day Notice |
| S028 | 2008-11-10 | 30-day Notice |
| S027 | 2007-09-27 | Normal 180 Day Track No User Fee |
| S026 | 2007-04-02 | 30-day Notice |
| S025 | 2006-12-21 | 30-day Notice |
| S024 | 2006-11-14 | 30-day Notice |
| S023 | 2006-08-02 | 30-day Notice |
| S022 | 2006-07-21 | 30-day Notice |
| S021 | ||
| S020 | 2006-07-14 | 135 Review Track For 30-day Notice |
| S019 | 2006-07-14 | 135 Review Track For 30-day Notice |
| S018 | 2006-07-10 | 135 Review Track For 30-day Notice |
| S017 | 2006-06-30 | Special (immediate Track) |
| S016 | 2006-06-29 | Special (immediate Track) |
| S015 | 2006-03-01 | 135 Review Track For 30-day Notice |
| S014 | 2006-02-28 | 30-day Notice |
| S013 | 2006-02-28 | 30-day Notice |
| S012 | 2006-02-28 | 30-day Notice |
| S011 | 2006-02-28 | 30-day Notice |
| S010 | 2006-02-28 | Real-time Process |
| S009 | 2006-02-28 | 135 Review Track For 30-day Notice |
| S008 | 2006-02-24 | Special (immediate Track) |
| S007 | 2006-02-24 | 30-day Notice |
| S006 | 2006-02-24 | 30-day Notice |
| S005 | 2006-02-24 | 30-day Notice |
| S004 | 2006-02-24 | 30-day Notice |
| S003 | 2005-12-22 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2004-09-16 | Normal 180 Day Track No User Fee |