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.
Addition of receiving inspection and testing activities of raw materials and supply items at the clonmel, ireland facility and contract laboratories.
| Device | OMNILINK ELITE VACULAR SYSTEM |
| Generic Name | Stent, Iliac |
| Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Date Received | 2014-04-14 |
| Decision Date | 2014-05-13 |
| PMA | P110043 |
| Supplement | S006 |
| 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 |