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 | REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire |
| Generic Name | Stent, Coronary |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130030 Supplement NumberS074 Date Received10/17/2022 Decision Date11/15/2022 Product Code MAF Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-17 |
| Decision Date | 2022-11-15 |
| PMA | P130030 |
| Supplement | S074 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 PMA NumberP130030 Supplement NumberS074 Date Received10/17/2022 Decision Date11/15/2022 Product Code MAF Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement change To A Sterilization Chamber At The Boston Scientific Corporation (BSC) Coventry Rhode Island Facility |
| 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 |