This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the rebel platinum chromium coronary stent system (monorail and over-the-wire). This device is indicated for improving coronary luminal diameter in patients with de novo lesions = 2. 25 to >= 4. 50 mm.
| Device | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | Boston Scientific Corp. |
| Date Received | 2013-12-30 |
| Decision Date | 2014-06-27 |
| Notice Date | 2014-07-23 |
| PMA | P130030 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 14M-1060 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130030 | Original Filing | |
| S074 | 2022-10-17 | 30-day Notice |
| S073 | 2022-01-28 | 30-day Notice |
| S072 | 2021-02-26 | 30-day Notice |
| S071 | 2020-11-20 | 30-day Notice |
| S070 | 2020-08-07 | 30-day Notice |
| S069 | 2020-06-05 | 30-day Notice |
| S068 | 2020-03-30 | 30-day Notice |
| S067 | ||
| S066 | 2020-02-11 | 30-day Notice |
| S065 | 2019-12-13 | 30-day Notice |
| S064 | 2019-11-22 | 30-day Notice |
| S063 | 2019-11-01 | 30-day Notice |
| S062 | 2019-10-10 | 30-day Notice |
| S061 | 2019-06-27 | 30-day Notice |
| S060 | 2019-05-21 | 30-day Notice |
| S059 | 2019-02-01 | 30-day Notice |
| S058 | 2018-12-21 | 30-day Notice |
| S057 | 2018-11-16 | 30-day Notice |
| S056 | 2018-10-05 | 30-day Notice |
| S055 | 2018-08-24 | 30-day Notice |
| S054 | 2018-08-17 | 30-day Notice |
| S053 | 2018-08-01 | 30-day Notice |
| S052 | 2018-06-13 | 30-day Notice |
| S051 | 2018-04-23 | 30-day Notice |
| S050 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S049 | 2018-02-20 | Normal 180 Day Track |
| S048 | 2018-01-17 | 30-day Notice |
| S047 | 2017-11-20 | 30-day Notice |
| S046 | 2017-10-30 | 30-day Notice |
| S045 | 2017-10-02 | 30-day Notice |
| S044 | 2017-08-18 | 30-day Notice |
| S043 | 2017-08-04 | 30-day Notice |
| S042 | 2017-07-18 | 30-day Notice |
| S041 | 2017-06-26 | 30-day Notice |
| S040 | 2017-05-05 | Real-time Process |
| S039 | 2017-04-13 | 30-day Notice |
| S038 | 2017-04-11 | 30-day Notice |
| S037 | 2017-03-06 | 30-day Notice |
| S036 | 2016-12-15 | Real-time Process |
| S035 | 2016-11-30 | Normal 180 Day Track No User Fee |
| S034 | 2016-11-23 | 30-day Notice |
| S033 | 2016-11-22 | 30-day Notice |
| S032 | 2016-11-14 | 30-day Notice |
| S031 | 2016-10-04 | Real-time Process |
| S030 | 2016-09-01 | 30-day Notice |
| S029 | ||
| S028 | 2016-08-08 | 30-day Notice |
| S027 | 2016-08-01 | 30-day Notice |
| S026 | 2016-07-21 | 30-day Notice |
| S025 | 2016-07-15 | 30-day Notice |
| S024 | 2016-04-13 | 30-day Notice |
| S023 | 2016-03-21 | 135 Review Track For 30-day Notice |
| S022 | 2016-02-22 | 30-day Notice |
| S021 | 2016-02-18 | 30-day Notice |
| S020 | 2016-01-28 | 30-day Notice |
| S019 | 2016-01-20 | Real-time Process |
| S018 | 2016-01-15 | 30-day Notice |
| S017 | 2015-09-25 | 135 Review Track For 30-day Notice |
| S016 | 2015-08-04 | 30-day Notice |
| S015 | 2015-06-09 | 30-day Notice |
| S014 | 2015-06-08 | 30-day Notice |
| S013 | ||
| S012 | 2015-04-29 | 30-day Notice |
| S011 | 2015-03-13 | 30-day Notice |
| S010 | 2015-02-23 | 30-day Notice |
| S009 | 2015-01-26 | 30-day Notice |
| S008 | 2014-12-19 | 30-day Notice |
| S007 | 2014-12-08 | Normal 180 Day Track No User Fee |
| S006 | 2014-09-30 | 30-day Notice |
| S005 | 2014-09-26 | 30-day Notice |
| S004 | 2014-09-22 | 30-day Notice |
| S003 | 2014-08-22 | 30-day Notice |
| S002 | 2014-07-28 | 30-day Notice |
| S001 | 2014-07-08 | 30-day Notice |