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 a change to the stent sub-assembly cleaning process that occurs prior to the electropolish process.
| Device | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2013-08-16 |
| Decision Date | 2014-01-16 |
| PMA | P110028 |
| Supplement | S011 |
| Product Code | NIO |
| 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 92054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110028 | Original Filing | |
| S023 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S022 | 2021-09-20 | 30-day Notice |
| S021 | 2020-08-05 | 30-day Notice |
| S020 | 2019-07-05 | 30-day Notice |
| S019 | 2018-06-26 | 30-day Notice |
| S018 | 2017-03-21 | 30-day Notice |
| S017 | 2017-03-16 | 30-day Notice |
| S016 | 2015-04-07 | 135 Review Track For 30-day Notice |
| S015 | 2015-02-24 | 30-day Notice |
| S014 | 2015-01-14 | 30-day Notice |
| S013 | 2014-07-18 | 30-day Notice |
| S012 | 2014-05-07 | 135 Review Track For 30-day Notice |
| S011 | 2013-08-16 | 135 Review Track For 30-day Notice |
| S010 | 2013-08-14 | 30-day Notice |
| S009 | 2013-07-29 | 30-day Notice |
| S008 | 2013-05-31 | 30-day Notice |
| S007 | 2013-01-14 | 30-day Notice |
| S006 | 2012-12-19 | 30-day Notice |
| S005 | 2012-10-15 | 30-day Notice |
| S004 | 2012-06-13 | 30-day Notice |
| S003 | 2012-05-24 | 30-day Notice |
| S002 | 2012-05-21 | 30-day Notice |
| S001 | 2012-05-11 | 30-day Notice |