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 misago peripheral self-expanding stent system. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and/or proximal popliteal artery with reference vessel diameters ranging from 4mm to 7mm and lesion length up to 150mm.
| 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 | 2014-03-06 |
| Decision Date | 2015-05-22 |
| Notice Date | 2015-06-05 |
| PMA | P140002 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 15M-1958 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TERUMO MEDICAL CORPORATION 950 Elkton Blvd elkton, MD 21921 |
| 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 |
|---|---|---|
| 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 |