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.
Use of an alternate strain relief component of the delivery system y-connector assembly
Device | Express LD Iliac Premounted Stent System |
Generic Name | Stent, Iliac |
Applicant | BOSTON SCIENTIFIC CORPORATION |
Date Received | 2021-03-01 |
Decision Date | 2021-04-30 |
PMA | P090003 |
Supplement | S051 |
Product Code | NIO |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
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 |