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.
| Device | EluNIR TM Ridaforolimus Eluting Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Medinol, Ltd.kiryat Atidim, Bldg. 8pob 58165tel Aviv 61581 PMA NumberP170008 Supplement NumberS040 Date Received03/22/2022 Decision Date04/14/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-04-14 |
| PMA | P170008 |
| Supplement | S040 |
| 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 PMA NumberP170008 Supplement NumberS040 Date Received03/22/2022 Decision Date04/14/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement to Establish New Cleanroom Parameters During Off Hours |
| 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 |