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.
Approval for labeling updates to the instructions for use (ifu) to reflect the long-term data from the post-approval blast placebo cohort study.
| Device | NIRXCELL COCR CORONARYSTENT ON RX SYSTEM |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | MEDINOL LTD. |
| Date Received | 2015-12-11 |
| Decision Date | 2017-08-07 |
| PMA | P110004 |
| Supplement | S015 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDINOL LTD. kiryat Atidim, Bldg. 7 entrance A, P.o.b. 58165 tel-aviv 61581 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110004 | Original Filing | |
| S035 | 2020-03-12 | 30-day Notice |
| S034 | 2019-10-25 | 30-day Notice |
| S033 | 2019-06-19 | 30-day Notice |
| S032 | 2019-03-15 | 30-day Notice |
| S031 | 2018-10-19 | 30-day Notice |
| S030 | 2018-05-25 | 30-day Notice |
| S029 | 2018-03-08 | 30-day Notice |
| S028 | 2018-02-21 | 135 Review Track For 30-day Notice |
| S027 | 2017-12-14 | 135 Review Track For 30-day Notice |
| S026 | 2017-11-20 | 30-day Notice |
| S025 | 2017-08-04 | 30-day Notice |
| S024 | 2017-07-17 | Normal 180 Day Track No User Fee |
| S023 | 2017-06-07 | Normal 180 Day Track No User Fee |
| S022 | 2017-05-08 | Special (immediate Track) |
| S021 | 2016-12-05 | Normal 180 Day Track No User Fee |
| S020 | 2016-07-26 | 30-day Notice |
| S019 | 2016-07-26 | 30-day Notice |
| S018 | 2016-07-21 | Normal 180 Day Track |
| S017 | 2016-04-26 | Normal 180 Day Track No User Fee |
| S016 | 2016-02-04 | 135 Review Track For 30-day Notice |
| S015 | 2015-12-11 | Normal 180 Day Track No User Fee |
| S014 | 2015-09-04 | 30-day Notice |
| S013 | 2015-09-04 | 30-day Notice |
| S012 | 2015-08-07 | 30-day Notice |
| S011 | 2015-02-19 | Special (immediate Track) |
| S010 | 2014-11-13 | Normal 180 Day Track No User Fee |
| S009 | ||
| S008 | ||
| S007 | ||
| S006 | 2014-05-05 | 30-day Notice |
| S005 | 2014-05-05 | 135 Review Track For 30-day Notice |
| S004 | 2014-05-05 | 30-day Notice |
| S003 | 2014-04-14 | 30-day Notice |
| S002 | 2014-02-14 | Real-time Process |
| S001 | 2013-02-22 | Normal 180 Day Track |