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.
Approval for automation of an inspection step.
| Device | E-LUMINEXX VASCULAR STENT |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2012-02-01 |
| Decision Date | 2012-09-27 |
| PMA | P080007 |
| Supplement | S011 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 |