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 modifications to the stent delivery system. The device, as modified, will be marketed under the trade name nirxcell cocr coronary stent on rx system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length ¿30mm) with a reference vessel diameter of 2. 50mm to 4. 00mm.
| Device | NIRXCELL COCR CORONARY STENT ON RX SYSTEM |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | MEDINOL LTD. |
| Date Received | 2013-02-22 |
| Decision Date | 2013-12-19 |
| PMA | P110004 |
| Supplement | S001 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDINOL LTD. kiryat Atidim, Bldg. 7 entrance A, P.o.b. 58165 tel-aviv 61581 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| 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 |