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 of the following changes to the post-approval study for the device: revisions to the exclusion criteria and clarification of the serious adverse event definition.
| Device | NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM) |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | MEDINOL LTD. |
| Date Received | 2016-04-26 |
| Decision Date | 2016-06-24 |
| PMA | P110004 |
| Supplement | S017 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |