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 boston scientific express sd renal monorail premounted stent system. The device is indicated as an adjunct to percutaneous transluminal renal angioplasty (ptra) of a single de novo or restenotic atherosclerotic lesion (
| Device | BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM |
| Classification Name | Stent, Renal |
| Generic Name | Stent, Renal |
| Applicant | Boston Scientific Corp. |
| Date Received | 2006-02-21 |
| Decision Date | 2008-12-11 |
| Notice Date | 2008-12-19 |
| PMA | P060006 |
| Supplement | S |
| Product Code | NIN |
| Docket Number | 08M-0646 |
| 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 Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |