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.
Updates to the programmable logic controller (plc) software used for sterilization chamber 3, an update to the vacuum pump system used in chamber 3, and an update to the validation documentation structure used to support the system.
| Device | Epic Vascular Self-Expanding Stent System |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Boston Scientific Corp. |
| Date Received | 2017-04-28 |
| Decision Date | 2017-05-26 |
| PMA | P110035 |
| Supplement | S040 |
| Product Code | NIO |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110035 | Original Filing | |
| S068 | 2022-10-18 | 30-day Notice |
| S067 | 2022-04-07 | 30-day Notice |
| S066 | 2021-03-10 | 30-day Notice |
| S065 | 2021-02-01 | 30-day Notice |
| S064 | 2020-12-03 | 30-day Notice |
| S063 | 2020-11-19 | 30-day Notice |
| S062 | 2020-08-21 | 30-day Notice |
| S061 | 2020-07-10 | 30-day Notice |
| S060 | ||
| S059 | 2020-03-27 | 30-day Notice |
| S058 | 2020-03-16 | 30-day Notice |
| S057 | ||
| S056 | ||
| S055 | 2020-01-27 | 30-day Notice |
| S054 | 2019-11-22 | 30-day Notice |
| S053 | 2019-09-30 | 30-day Notice |
| S052 | 2019-08-14 | 30-day Notice |
| S051 | 2019-06-27 | 30-day Notice |
| S050 | 2019-05-21 | 30-day Notice |
| S049 | 2019-05-06 | 30-day Notice |
| S048 | 2018-10-09 | 30-day Notice |
| S047 | 2018-09-19 | 30-day Notice |
| S046 | 2018-06-01 | 30-day Notice |
| S045 | 2018-03-05 | 30-day Notice |
| S044 | 2017-11-20 | 30-day Notice |
| S043 | 2017-10-12 | 30-day Notice |
| S042 | 2017-09-22 | Real-time Process |
| S041 | 2017-05-30 | 30-day Notice |
| S040 | 2017-04-28 | 30-day Notice |
| S039 | 2017-04-11 | 30-day Notice |
| S038 | 2016-10-03 | 30-day Notice |
| S037 | 2016-08-08 | 30-day Notice |
| S036 | 2016-06-15 | Normal 180 Day Track No User Fee |
| S035 | 2016-06-09 | 135 Review Track For 30-day Notice |
| S034 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S033 | 2015-09-09 | 30-day Notice |
| S032 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S031 | 2015-02-25 | 30-day Notice |
| S030 | 2015-02-05 | 30-day Notice |
| S029 | 2015-01-22 | 30-day Notice |
| S028 | 2014-07-29 | 30-day Notice |
| S027 | 2014-04-25 | 30-day Notice |
| S026 | 2014-04-24 | 135 Review Track For 30-day Notice |
| S025 | 2014-04-21 | 30-day Notice |
| S024 | 2013-11-18 | 30-day Notice |
| S023 | 2013-10-31 | 30-day Notice |
| S022 | 2013-09-27 | 30-day Notice |
| S021 | 2013-09-20 | 30-day Notice |
| S020 | 2013-09-19 | 30-day Notice |
| S019 | 2013-08-29 | 30-day Notice |
| S018 | 2013-07-17 | 30-day Notice |
| S017 | 2013-06-24 | 30-day Notice |
| S016 | 2013-06-10 | 30-day Notice |
| S015 | 2013-06-07 | 30-day Notice |
| S014 | 2013-05-09 | 30-day Notice |
| S013 | 2013-05-01 | 30-day Notice |
| S012 | 2013-03-26 | Real-time Process |
| S011 | 2013-03-21 | 30-day Notice |
| S010 | 2013-03-11 | 30-day Notice |
| S009 | ||
| S008 | ||
| S007 | 2013-01-29 | 30-day Notice |
| S006 | 2013-01-28 | 30-day Notice |
| S005 | 2012-11-19 | 30-day Notice |
| S004 | 2012-10-11 | 30-day Notice |
| S003 | 2012-09-05 | 30-day Notice |
| S002 | 2012-06-13 | 30-day Notice |
| S001 | 2012-05-07 | 30-day Notice |