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 epic vascular self-expanding stent system. This device is indicated for the improvement of luminal diameter in patients with de novo or restenotic symptomatic atherosclerotic lesions up to 120 mm in length in the common and/or external iliac arteries, with a reference vessel diameter between 5 and 11 mm.
| Device | EPIC SELF-EXPANDING NITINOL STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Boston Scientific Corp. |
| Date Received | 2011-09-13 |
| Decision Date | 2012-04-13 |
| Notice Date | 2012-04-25 |
| PMA | P110035 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 12M-0373 |
| 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 |
| Approval Order: | Approval Order |
| 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 |