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 changes to the device delivery system, associated labeling changes, new manufacturing equipment and new material suppliers.
| Device | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | TERUMO MEDICAL CORPORATION |
| Date Received | 2016-05-06 |
| Decision Date | 2017-03-08 |
| PMA | P140002 |
| Supplement | S002 |
| 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 | TERUMO MEDICAL CORPORATION 950 Elkton Blvd elkton, MD 21921 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140002 | Original Filing | |
| S023 | 2022-10-26 | 30-day Notice |
| S022 | 2022-09-21 | 30-day Notice |
| S021 | 2021-05-10 | 30-day Notice |
| S020 | 2019-11-06 | 30-day Notice |
| S019 | 2018-12-19 | 135 Review Track For 30-day Notice |
| S018 | 2018-10-12 | 30-day Notice |
| S017 | 2018-08-27 | 30-day Notice |
| S016 | 2018-05-04 | 30-day Notice |
| S015 | ||
| S014 | 2018-04-19 | 135 Review Track For 30-day Notice |
| S013 | 2018-04-18 | 135 Review Track For 30-day Notice |
| S012 | 2018-04-04 | 30-day Notice |
| S011 | 2018-04-02 | 135 Review Track For 30-day Notice |
| S010 | ||
| S009 | 2017-09-14 | 135 Review Track For 30-day Notice |
| S008 | 2017-09-14 | 30-day Notice |
| S007 | 2016-12-06 | 30-day Notice |
| S006 | 2016-09-21 | 135 Review Track For 30-day Notice |
| S005 | 2016-09-21 | 30-day Notice |
| S004 | 2016-09-19 | 30-day Notice |
| S003 | 2016-09-19 | 30-day Notice |
| S002 | 2016-05-06 | Normal 180 Day Track |
| S001 | 2015-05-26 | 30-day Notice |