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 automated equipment in the packaging process.
| Device | Express SD Renal Monorail Premounted Stent System |
| Classification Name | Stent, Renal |
| Generic Name | Stent, Renal |
| Applicant | Boston Scientific Corp. |
| Date Received | 2017-11-20 |
| Decision Date | 2017-12-15 |
| PMA | P060006 |
| Supplement | S089 |
| Product Code | NIN |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |
|---|---|---|
| P060006 | Original Filing | |
| S104 | 2022-10-17 | 30-day Notice |
| S103 | 2022-01-28 | 30-day Notice |
| S102 | 2020-10-19 | 30-day Notice |
| S101 | 2020-08-06 | 30-day Notice |
| S100 | 2020-03-12 | Normal 180 Day Track No User Fee |
| S099 | 2020-02-11 | 30-day Notice |
| S098 | 2019-10-10 | 30-day Notice |
| S097 | 2019-06-27 | 30-day Notice |
| S096 | 2019-05-21 | 30-day Notice |
| S095 | 2018-12-03 | 30-day Notice |
| S094 | 2018-09-10 | 30-day Notice |
| S093 | 2018-08-24 | 30-day Notice |
| S092 | 2018-06-13 | 30-day Notice |
| S091 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S090 | 2018-01-17 | 30-day Notice |
| S089 | 2017-11-20 | 30-day Notice |
| S088 | 2017-10-30 | 30-day Notice |
| S087 | 2017-10-02 | 30-day Notice |
| S086 | 2017-08-18 | 30-day Notice |
| S085 | 2017-08-04 | 30-day Notice |
| S084 | 2017-07-18 | 30-day Notice |
| S083 | 2017-06-26 | 30-day Notice |
| S082 | 2017-04-13 | 30-day Notice |
| S081 | 2017-04-11 | 30-day Notice |
| S080 | 2017-03-06 | 30-day Notice |
| S079 | 2017-02-16 | 30-day Notice |
| S078 | 2016-08-08 | 30-day Notice |
| S077 | 2016-07-21 | 30-day Notice |
| S076 | 2016-07-13 | 30-day Notice |
| S075 | 2016-06-15 | Normal 180 Day Track No User Fee |
| S074 | 2016-06-13 | 30-day Notice |
| S073 | 2016-02-29 | Real-time Process |
| S072 | 2016-02-18 | 30-day Notice |
| S071 | 2016-01-28 | 30-day Notice |
| S070 | 2015-09-02 | Real-time Process |
| S069 | 2015-08-04 | 30-day Notice |
| S068 | ||
| S067 | 2015-04-29 | 30-day Notice |
| S066 | 2015-02-23 | 30-day Notice |
| S065 | 2015-02-05 | 30-day Notice |
| S064 | 2014-11-14 | 135 Review Track For 30-day Notice |
| S063 | 2014-06-24 | 30-day Notice |
| S062 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S061 | 2014-06-02 | 30-day Notice |
| S060 | 2014-04-28 | 135 Review Track For 30-day Notice |
| S059 | 2014-03-31 | 30-day Notice |
| S058 | 2014-03-28 | 30-day Notice |
| S057 | 2014-02-25 | 30-day Notice |
| S056 | 2014-02-24 | 30-day Notice |
| S055 | 2014-02-21 | 30-day Notice |
| S054 | 2014-01-14 | 30-day Notice |
| S053 | 2013-12-30 | 30-day Notice |
| S052 | 2013-11-26 | 30-day Notice |
| S051 | 2013-11-25 | 30-day Notice |
| S050 | 2013-09-20 | 30-day Notice |
| S049 | 2013-09-19 | 30-day Notice |
| S048 | 2013-08-29 | 30-day Notice |
| S047 | 2013-06-10 | 30-day Notice |
| S046 | 2013-05-23 | 30-day Notice |
| S045 | ||
| S044 | ||
| S043 | 2013-03-29 | Real-time Process |
| S042 | ||
| S041 | 2013-01-28 | 30-day Notice |
| S040 | 2013-01-16 | 30-day Notice |
| S039 | 2012-11-27 | 30-day Notice |
| S038 | 2012-11-19 | 30-day Notice |
| S037 | 2012-11-16 | 30-day Notice |
| S036 | 2012-11-02 | 30-day Notice |
| S035 | 2012-10-15 | 30-day Notice |
| S034 | 2012-10-11 | 30-day Notice |
| S033 | 2012-09-05 | 30-day Notice |
| S032 | 2012-08-03 | 30-day Notice |
| S031 | 2012-07-13 | 135 Review Track For 30-day Notice |
| S030 | 2012-06-27 | 135 Review Track For 30-day Notice |
| S029 | 2012-06-06 | 30-day Notice |
| S028 | 2012-05-02 | 30-day Notice |
| S027 | 2012-04-27 | 30-day Notice |
| S026 | 2012-04-18 | 30-day Notice |
| S025 | 2012-03-23 | 30-day Notice |
| S024 | 2012-02-03 | 30-day Notice |
| S023 | 2011-11-14 | 30-day Notice |
| S022 | 2011-11-07 | 30-day Notice |
| S021 | 2011-06-21 | Normal 180 Day Track No User Fee |
| S020 | 2011-04-01 | 30-day Notice |
| S019 | 2010-12-22 | 135 Review Track For 30-day Notice |
| S018 | 2010-12-14 | 30-day Notice |
| S017 | 2010-10-07 | 135 Review Track For 30-day Notice |
| S016 | 2010-09-13 | 30-day Notice |
| S015 | 2010-08-02 | 30-day Notice |
| S014 | 2010-06-07 | 135 Review Track For 30-day Notice |
| S013 | 2010-05-17 | 135 Review Track For 30-day Notice |
| S012 | 2010-04-15 | 30-day Notice |
| S011 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S010 | 2010-03-08 | Real-time Process |
| S009 | 2010-03-08 | 30-day Notice |
| S008 | ||
| S007 | 2010-02-01 | 30-day Notice |
| S006 | 2010-01-27 | Normal 180 Day Track |
| S005 | 2010-01-26 | 30-day Notice |
| S004 | 2009-11-10 | 135 Review Track For 30-day Notice |
| S003 | 2009-11-06 | 30-day Notice |
| S002 | 2009-11-05 | 30-day Notice |
| S001 | 2009-11-05 | 30-day Notice |