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 removal of stent mass as a final product specification for the rx acculink carotid stent system and modification of the specifications regarding allowable contaminant in the device packaging.
| Device | RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2006-02-28 |
| Decision Date | 2006-03-14 |
| PMA | P040012 |
| Supplement | S010 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |