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.
Replace the current thermal bonding machine used in the distal bonding process of the catheter.
| Device | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2015-03-15 |
| Decision Date | 2015-04-02 |
| PMA | P110023 |
| Supplement | S014 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |