This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the everflex self-expanding peripheral stent system. This device is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 180mm in length in the native superficial femoral artery (sfa) and/or proximal popliteal arteries with reference vessel diameters ranging from 4. 5 -7. 5mm.
| Device | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2011-06-13 |
| Decision Date | 2012-03-07 |
| Notice Date | 2012-03-14 |
| PMA | P110023 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 12M-0221 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |