This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the absolute pro vascular self-expanding stent system. The device is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4. 3 mm and 9. 1 mm and lesions lengths up to 90 mm.
| Device | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2011-07-25 |
| Decision Date | 2012-02-22 |
| Notice Date | 2012-02-27 |
| PMA | P110028 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 12M-0181 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 92054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |