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.
Modified extrusion process parameters and changes to in-process inspection specifications.
| Device | MISAGO RX SELF-EXPANDING PERIPHERAL STENT |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | TERUMO MEDICAL CORPORATION |
| Date Received | 2016-09-19 |
| Decision Date | 2016-10-18 |
| PMA | P140002 |
| Supplement | S003 |
| 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 | 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 |