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.
Minor changes to the packaging process for the sterile barrier system of the misago rx self-expanding peripheral stent ("misago") system.
| 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 | 2018-10-12 |
| Decision Date | 2018-11-09 |
| PMA | P140002 |
| Supplement | S018 |
| 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 |