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.
To implement an alternative external process challenge device (epcd) used in the sterilization process
| Device | Bard E-Luminexx and LifeStar Vascular Stent |
| Generic Name | Stent, Iliac |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2021-07-09 |
| Decision Date | 2021-08-05 |
| PMA | P080007 |
| Supplement | S025 |
| 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 | BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080007 | Original Filing | |
| S027 | 2022-05-02 | 30-day Notice |
| S026 | 2021-08-26 | Real-time Process |
| S025 | 2021-07-09 | 30-day Notice |
| S024 | 2021-02-25 | 30-day Notice |
| S023 | 2020-05-01 | 30-day Notice |
| S022 | 2019-06-18 | 30-day Notice |
| S021 | 2017-12-15 | 30-day Notice |
| S020 | 2014-03-24 | 30-day Notice |
| S019 | 2013-12-24 | Special (immediate Track) |
| S018 | 2013-08-19 | 30-day Notice |
| S017 | 2013-06-04 | 30-day Notice |
| S016 | 2013-03-29 | 30-day Notice |
| S015 | 2012-11-09 | Normal 180 Day Track No User Fee |
| S014 | 2012-05-21 | 30-day Notice |
| S013 | 2012-04-02 | 30-day Notice |
| S012 | ||
| S011 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S010 | 2011-11-14 | 30-day Notice |
| S009 | 2011-10-28 | 30-day Notice |
| S008 | 2011-10-21 | 30-day Notice |
| S007 | 2011-09-26 | Real-time Process |
| S006 | ||
| S005 | 2011-03-11 | 135 Review Track For 30-day Notice |
| S004 | 2010-08-12 | 30-day Notice |
| S003 | 2010-03-19 | 135 Review Track For 30-day Notice |
| S002 | ||
| S001 | 2009-01-28 | 30-day Notice |