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.
Modification to the ethylene oxide sterilization dunnage configuration layers and pallet dimensions
| Device | XACT Carotid Stent System |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2019-02-08 |
| Decision Date | 2019-03-14 |
| PMA | P040038 |
| Supplement | S035 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 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 |
| 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 |