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.
Removal of a redundant tensile test inspection and implementation of a new mold.
| Device | EPIC VACULAR SELF EXPANDING STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Boston Scientific Corp. |
| Date Received | 2013-11-18 |
| Decision Date | 2013-12-18 |
| PMA | P110035 |
| Supplement | S024 |
| 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 |