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 the rx acculink carotid stent system. The device is indicated for high surgical risk and standard surgical risk patients as follows: high surgical risk -the rx acculink carotid stent system, used in conjunction with abbott vascular's accunet or emboshield family of embolic protection systems (eps), is indicated for the treatment of 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 patients must have a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion. Standard surgical risk - the rx acculink carotid stent system, used in conjunction with the accunet embolic protection system (eps), is indicated for the treatment of patients at standard risk for adverse events from cartoid endarterectomy who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >= 70% stenosis of the common or internal carotid artery by ultrasound or >= 50% stenosis of the common or internal carotid artery by angiogram or patients without neurological symptoms and >= 70% stenosis of the common or internal carotid artery by ultrasound or >= 60% stenosis of the common or internal carotid artery by angiogram; and 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 | 2010-10-01 |
| Decision Date | 2011-05-06 |
| Notice Date | 2011-05-12 |
| PMA | P040012 |
| Supplement | S034 |
| Product Code | NIM |
| Docket Number | 11M-0343 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| 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 |