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.
Changes to the sampling plan for the mechanical and packaging release testing
| Device | EluNIR Ridaforolimus Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Medinol, Ltd. |
| Date Received | 2020-07-23 |
| Decision Date | 2020-08-20 |
| PMA | P170008 |
| Supplement | S028 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medinol, Ltd. kiryat Atidim, Bldg. 8 pob 58165 tel Aviv 61581 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170008 | Original Filing | |
| S041 | 2022-03-22 | 30-day Notice |
| S040 | 2022-03-22 | 30-day Notice |
| S039 | 2022-03-22 | 30-day Notice |
| S038 | 2021-11-12 | Normal 180 Day Track |
| S037 | ||
| S036 | 2021-05-17 | 30-day Notice |
| S035 | 2021-03-18 | 30-day Notice |
| S034 | 2021-03-08 | 30-day Notice |
| S033 | 2021-03-01 | 30-day Notice |
| S032 | ||
| S031 | 2020-11-23 | 30-day Notice |
| S030 | 2020-11-09 | 30-day Notice |
| S029 | 2020-10-26 | 30-day Notice |
| S028 | 2020-07-23 | 30-day Notice |
| S027 | ||
| S026 | ||
| S025 | 2020-03-12 | 30-day Notice |
| S024 | ||
| S023 | ||
| S022 | 2019-10-25 | 30-day Notice |
| S021 | 2019-08-22 | 30-day Notice |
| S020 | 2019-07-18 | 30-day Notice |
| S019 | ||
| S018 | 2019-06-19 | 30-day Notice |
| S017 | ||
| S016 | 2019-04-15 | 30-day Notice |
| S015 | 2019-03-15 | 30-day Notice |
| S014 | ||
| S013 | 2019-01-24 | 30-day Notice |
| S012 | 2019-01-17 | 30-day Notice |
| S011 | 2018-10-31 | 135 Review Track For 30-day Notice |
| S010 | 2018-10-19 | 30-day Notice |
| S009 | ||
| S008 | 2018-06-21 | 135 Review Track For 30-day Notice |
| S007 | 2018-06-20 | 30-day Notice |
| S006 | 2018-06-20 | 30-day Notice |
| S005 | 2018-05-25 | 30-day Notice |
| S004 | 2018-03-15 | Normal 180 Day Track No User Fee |
| S003 | 2018-03-08 | 30-day Notice |
| S002 | 2018-02-21 | 135 Review Track For 30-day Notice |
| S001 | 2018-01-29 | 30-day Notice |