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.
Reduce the number of samples used from each lot during pyrogen testing.
| Device | ABSOLUTE PRO, ABSOLUTE PRO LL |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2012-05-24 |
| Decision Date | 2012-06-21 |
| PMA | P110028 |
| Supplement | S003 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| 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 |