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.
To replace uv irradiation equipment
Device | MISAGO RX Self-expanding Peripheral Stent System |
Generic Name | Stent, Superficial Femoral Artery |
Applicant | TERUMO MEDICAL CORPORATION |
Date Received | 2021-05-10 |
Decision Date | 2021-06-09 |
PMA | P140002 |
Supplement | S021 |
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 |