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.
Approval for a manufacturing site located at boston scientific, 2 scimed place, maple grove, minnesota, for stent finishing, inspection, and cleaning.
| Device | EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2016-06-15 |
| Decision Date | 2016-08-11 |
| PMA | P090003 |
| Supplement | S042 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090003 | Original Filing | |
| S053 | 2022-11-14 | 30-day Notice |
| S052 | 2022-08-19 | 30-day Notice |
| S051 | 2021-03-01 | Real-time Process |
| S050 | 2020-10-19 | 30-day Notice |
| S049 | 2020-02-11 | 30-day Notice |
| S048 | 2019-06-27 | 30-day Notice |
| S047 | 2019-05-21 | 30-day Notice |
| S046 | 2019-05-03 | 30-day Notice |
| S045 | 2019-03-22 | 30-day Notice |
| S044 | 2018-09-10 | 30-day Notice |
| S043 | 2017-08-18 | 30-day Notice |
| S042 | 2016-06-15 | Normal 180 Day Track No User Fee |
| S041 | 2016-06-13 | 30-day Notice |
| S040 | 2016-02-25 | 30-day Notice |
| S039 | 2016-02-18 | 30-day Notice |
| S038 | 2015-02-05 | 30-day Notice |
| S037 | 2014-11-14 | 135 Review Track For 30-day Notice |
| S036 | ||
| S035 | 2014-07-22 | Real-time Process |
| S034 | ||
| S033 | 2014-06-02 | 30-day Notice |
| S032 | 2014-04-28 | 135 Review Track For 30-day Notice |
| S031 | 2014-04-07 | 30-day Notice |
| S030 | 2013-12-30 | 30-day Notice |
| S029 | 2013-09-30 | Real-time Process |
| S028 | 2013-09-20 | 30-day Notice |
| S027 | 2013-08-29 | 30-day Notice |
| S026 | 2013-07-24 | 30-day Notice |
| S025 | 2013-06-19 | 30-day Notice |
| S024 | 2013-06-10 | 30-day Notice |
| S023 | ||
| S022 | ||
| S021 | 2013-02-04 | 30-day Notice |
| S020 | 2012-11-27 | 30-day Notice |
| S019 | 2012-11-19 | 30-day Notice |
| S018 | 2012-10-03 | 30-day Notice |
| S017 | 2012-09-28 | 30-day Notice |
| S016 | 2012-09-19 | 30-day Notice |
| S015 | 2012-08-13 | 30-day Notice |
| S014 | 2012-07-13 | 135 Review Track For 30-day Notice |
| S013 | 2012-07-05 | 30-day Notice |
| S012 | 2012-04-20 | 30-day Notice |
| S011 | 2011-04-29 | 30-day Notice |
| S010 | 2011-02-22 | 30-day Notice |
| S009 | 2011-02-08 | 30-day Notice |
| S008 | 2010-12-14 | 30-day Notice |
| S007 | 2010-09-13 | 30-day Notice |
| S006 | 2010-09-13 | 30-day Notice |
| S005 | 2010-07-06 | 135 Review Track For 30-day Notice |
| S004 | 2010-06-18 | 30-day Notice |
| S003 | 2010-05-17 | 135 Review Track For 30-day Notice |
| S002 | 2010-05-17 | 30-day Notice |
| S001 | 2010-04-15 | 30-day Notice |