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.
| Device | XACT Carotid Stent System |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040038 Supplement NumberS041 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-21 |
| Decision Date | 2023-01-31 |
| PMA | P040038 |
| Supplement | S041 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054 PMA NumberP040038 Supplement NumberS041 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A Change In Supplier's Adhesive Formulation And Manufacturing. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040038 | Original Filing | |
| S041 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S040 | 2022-06-14 | 30-day Notice |
| S039 | 2021-11-12 | 30-day Notice |
| S038 | 2021-10-29 | 30-day Notice |
| S037 | ||
| S036 | 2020-08-06 | 30-day Notice |
| S035 | 2019-02-08 | 30-day Notice |
| S034 | 2019-01-24 | 30-day Notice |
| S033 | 2018-09-05 | 30-day Notice |
| S032 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S031 | 2016-05-09 | Normal 180 Day Track No User Fee |
| S030 | 2013-09-30 | 30-day Notice |
| S029 | 2013-05-14 | 30-day Notice |
| S028 | 2012-12-19 | 30-day Notice |
| S027 | 2012-06-13 | 30-day Notice |
| S026 | 2012-06-11 | 30-day Notice |
| S025 | 2012-05-24 | 30-day Notice |
| S024 | 2012-02-27 | Normal 180 Day Track No User Fee |
| S023 | 2011-08-03 | 30-day Notice |
| S022 | 2011-08-02 | 30-day Notice |
| S021 | 2011-02-28 | 30-day Notice |
| S020 | 2009-10-21 | 30-day Notice |
| S019 | 2009-05-26 | Normal 180 Day Track No User Fee |
| S018 | 2009-02-13 | Normal 180 Day Track No User Fee |
| S017 | 2009-02-11 | 30-day Notice |
| S016 | 2009-02-09 | Real-time Process |
| S015 | 2008-12-15 | Normal 180 Day Track No User Fee |
| S014 | 2008-07-10 | 135 Review Track For 30-day Notice |
| S013 | 2008-06-09 | 135 Review Track For 30-day Notice |
| S012 | 2007-12-18 | Normal 180 Day Track No User Fee |
| S011 | ||
| S010 | 2007-03-02 | 30-day Notice |
| S009 | 2006-12-26 | 30-day Notice |
| S008 | 2006-12-18 | Real-time Process |
| S007 | 2006-11-13 | Normal 180 Day Track No User Fee |
| S006 | 2006-07-10 | 135 Review Track For 30-day Notice |
| S005 | ||
| S004 | 2006-06-22 | Special (immediate Track) |
| S003 | 2006-07-14 | 135 Review Track For 30-day Notice |
| S002 | 2006-06-19 | 30-day Notice |
| S001 | 2005-09-29 | Normal 180 Day Track No User Fee |