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 to add the 5f entrust otw delivery system. The device, as modified, will be marketed under the trade name everflex self-expanding peripheral stent with entrust delivery system and is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140mm 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 WITH ENTRUST DELIVERY SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2014-08-22 |
| Decision Date | 2015-04-29 |
| PMA | P110023 |
| Supplement | S012 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |