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 acculink carotid stent system and rx acculink carotid stent system. The acculink carotid stent system and the rx acculink carotid stent system, used in conjunction with guidant carotid embolic protection systems, are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy 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, and2) patients must have a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion.
| Device | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2004-03-15 |
| Decision Date | 2004-08-30 |
| Notice Date | 2004-09-03 |
| PMA | P040012 |
| Supplement | S |
| Product Code | NIM |
| Docket Number | 04M-0388 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |