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.
Labeling updates with the final results of the durability post-approval study
| Device | EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2019-08-27 |
| Decision Date | 2019-11-20 |
| PMA | P110023 |
| Supplement | S028 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110023 | Original Filing | |
| S036 | 2022-11-15 | 30-day Notice |
| S035 | 2022-05-25 | 30-day Notice |
| S034 | ||
| S033 | 2021-12-13 | 30-day Notice |
| S032 | 2021-04-08 | 30-day Notice |
| S031 | 2020-12-10 | 30-day Notice |
| S030 | 2020-07-21 | 30-day Notice |
| S029 | 2020-05-06 | Real-time Process |
| S028 | 2019-08-27 | Normal 180 Day Track No User Fee |
| S027 | 2019-05-24 | 30-day Notice |
| S026 | 2019-05-03 | 30-day Notice |
| S025 | 2019-02-19 | 30-day Notice |
| S024 | 2017-11-03 | 30-day Notice |
| S023 | 2016-12-07 | 30-day Notice |
| S022 | 2016-11-02 | 30-day Notice |
| S021 | 2016-09-28 | Normal 180 Day Track No User Fee |
| S020 | 2016-07-05 | 30-day Notice |
| S019 | 2016-06-06 | 30-day Notice |
| S018 | 2016-03-22 | 30-day Notice |
| S017 | ||
| S016 | 2015-11-20 | 30-day Notice |
| S015 | 2015-03-23 | 135 Review Track For 30-day Notice |
| S014 | 2015-03-15 | 30-day Notice |
| S013 | 2014-11-17 | 30-day Notice |
| S012 | 2014-08-22 | Normal 180 Day Track |
| S011 | 2014-07-21 | 30-day Notice |
| S010 | 2014-07-10 | Normal 180 Day Track No User Fee |
| S009 | 2014-06-05 | 30-day Notice |
| S008 | 2014-06-03 | 30-day Notice |
| S007 | 2014-04-14 | Panel Track |
| S006 | 2014-02-03 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2012-10-09 | 30-day Notice |
| S003 | 2012-06-11 | 30-day Notice |
| S002 | 2012-05-16 | 30-day Notice |
| S001 | 2012-04-24 | 30-day Notice |