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 omnilink elite vascular balloon-expandable stent system. This device is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of >= 5. 0 mm and
| Device | OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM |
| Generic Name | Stent, Iliac |
| Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Date Received | 2011-12-30 |
| Decision Date | 2012-07-31 |
| Notice Date | 2012-08-03 |
| PMA | P110043 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 12M-0833 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR-CARDIAC THERAPIES 3200 Lakeside Dr. santa Clara, CA 95054-2807 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110043 | Original Filing | |
| S013 | 2022-08-09 | 30-day Notice |
| S012 | 2020-08-14 | 30-day Notice |
| S011 | 2016-08-19 | 30-day Notice |
| S010 | 2016-04-29 | 30-day Notice |
| S009 | 2014-09-02 | 30-day Notice |
| S008 | 2014-08-27 | 30-day Notice |
| S007 | 2014-08-08 | 30-day Notice |
| S006 | 2014-04-14 | 30-day Notice |
| S005 | ||
| S004 | 2013-11-08 | 30-day Notice |
| S003 | 2012-10-01 | Normal 180 Day Track No User Fee |
| S002 | 2012-08-27 | 30-day Notice |
| S001 | 2012-08-24 | 30-day Notice |