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.
Alternate sampling plan for process monitoring.
| Device | OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM |
| Generic Name | Stent, Iliac |
| Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Date Received | 2016-04-29 |
| Decision Date | 2016-05-27 |
| PMA | P110043 |
| Supplement | S010 |
| Product Code | NIO |
| 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-CARDIAC THERAPIES 3200 Lakeside Dr. santa Clara, CA 95054-2807 |
| 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 |