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 design, manufacturing, and labeling changes in the cutting balloon, both over-the-wire (otw) and monorail (mr) configurations. The device, as modified, will be marketed under the trade name flextome cutting balloon and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.
| Device | FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal |
| Generic Name | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Boston Scientific Corp. |
| Date Received | 2004-09-13 |
| Decision Date | 2005-07-18 |
| PMA | P950020 |
| Supplement | S010 |
| Product Code | LIT |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950020 | Original Filing | |
| S134 | 2023-01-10 | 30-day Notice |
| S133 | ||
| S132 | 2022-12-02 | 30-day Notice |
| S131 | 2022-11-15 | 30-day Notice |
| S130 | ||
| S129 | 2022-10-25 | 30-day Notice |
| S128 | ||
| S127 | 2022-10-11 | 30-day Notice |
| S126 | 2022-09-19 | 30-day Notice |
| S125 | 2022-09-06 | 30-day Notice |
| S124 | 2022-07-11 | 30-day Notice |
| S123 | 2022-06-17 | 30-day Notice |
| S122 | 2022-04-29 | 30-day Notice |
| S121 | ||
| S120 | 2022-03-14 | 30-day Notice |
| S119 | ||
| S118 | 2022-03-03 | 30-day Notice |
| S117 | 2022-02-11 | 30-day Notice |
| S116 | 2022-01-28 | 30-day Notice |
| S115 | 2021-11-22 | 30-day Notice |
| S114 | 2021-11-15 | 30-day Notice |
| S113 | 2021-08-24 | 30-day Notice |
| S112 | ||
| S111 | 2020-11-19 | 30-day Notice |
| S110 | 2020-11-12 | 30-day Notice |
| S109 | 2020-08-25 | 30-day Notice |
| S108 | 2020-06-09 | 30-day Notice |
| S107 | 2020-03-30 | 30-day Notice |
| S106 | ||
| S105 | 2020-02-27 | 30-day Notice |
| S104 | 2020-02-05 | 30-day Notice |
| S103 | 2020-02-05 | 30-day Notice |
| S102 | 2020-01-28 | 30-day Notice |
| S101 | 2020-01-23 | 30-day Notice |
| S100 | 2019-12-13 | 30-day Notice |
| S099 | 2019-10-10 | 30-day Notice |
| S098 | 2019-06-27 | 30-day Notice |
| S097 | ||
| S096 | 2019-03-12 | 30-day Notice |
| S095 | 2019-02-07 | 30-day Notice |
| S094 | 2019-02-01 | 30-day Notice |
| S093 | 2019-01-23 | 30-day Notice |
| S092 | 2018-11-16 | 30-day Notice |
| S091 | 2018-10-05 | 30-day Notice |
| S090 | 2018-08-17 | 30-day Notice |
| S089 | 2018-02-16 | 30-day Notice |
| S088 | 2018-01-09 | 30-day Notice |
| S087 | 2017-10-17 | 30-day Notice |
| S086 | 2017-10-16 | 30-day Notice |
| S085 | ||
| S084 | 2017-09-29 | 30-day Notice |
| S083 | 2017-08-08 | 30-day Notice |
| S082 | 2017-08-04 | 30-day Notice |
| S081 | 2017-07-20 | 30-day Notice |
| S080 | 2017-04-11 | 30-day Notice |
| S079 | 2016-11-30 | Normal 180 Day Track No User Fee |
| S078 | 2016-11-22 | 30-day Notice |
| S077 | 2016-11-17 | 30-day Notice |
| S076 | 2016-11-02 | 30-day Notice |
| S075 | 2016-09-01 | 30-day Notice |
| S074 | ||
| S073 | 2016-05-12 | 30-day Notice |
| S072 | 2016-01-29 | Normal 180 Day Track |
| S071 | 2015-01-07 | 30-day Notice |
| S070 | ||
| S069 | 2014-08-26 | 30-day Notice |
| S068 | 2014-07-31 | 30-day Notice |
| S067 | 2014-01-17 | 30-day Notice |
| S066 | 2013-11-26 | 30-day Notice |
| S065 | 2013-09-20 | 30-day Notice |
| S064 | 2013-08-29 | 30-day Notice |
| S063 | 2013-06-10 | 30-day Notice |
| S062 | ||
| S061 | 2013-03-29 | Real-time Process |
| S060 | 2013-01-14 | 30-day Notice |
| S059 | 2012-11-19 | 30-day Notice |
| S058 | 2012-11-15 | 30-day Notice |
| S057 | 2012-11-13 | 30-day Notice |
| S056 | 2012-10-17 | 30-day Notice |
| S055 | 2012-10-10 | Normal 180 Day Track |
| S054 | 2012-09-05 | 30-day Notice |
| S053 | 2012-08-16 | 30-day Notice |
| S052 | 2012-08-13 | 30-day Notice |
| S051 | 2012-06-14 | 30-day Notice |
| S050 | 2012-05-21 | 30-day Notice |
| S049 | 2012-02-29 | 30-day Notice |
| S048 | 2011-12-13 | 135 Review Track For 30-day Notice |
| S047 | 2011-11-04 | 30-day Notice |
| S046 | 2011-07-05 | 30-day Notice |
| S045 | 2011-06-21 | 30-day Notice |
| S044 | 2011-06-01 | 30-day Notice |
| S043 | ||
| S042 | 2010-12-22 | 135 Review Track For 30-day Notice |
| S041 | ||
| S040 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S039 | 2010-03-12 | 30-day Notice |
| S038 | 2010-01-26 | 30-day Notice |
| S037 | 2010-01-26 | 30-day Notice |
| S036 | 2009-11-12 | Normal 180 Day Track No User Fee |
| S035 | 2009-10-01 | 135 Review Track For 30-day Notice |
| S034 | 2009-08-31 | 30-day Notice |
| S033 | ||
| S032 | 2009-03-03 | Normal 180 Day Track No User Fee |
| S031 | 2008-12-17 | 30-day Notice |
| S030 | 2008-09-05 | 30-day Notice |
| S029 | 2008-05-19 | 30-day Notice |
| S028 | ||
| S027 | 2008-05-05 | 30-day Notice |
| S026 | 2008-02-19 | 30-day Notice |
| S025 | 2007-01-24 | 30-day Notice |
| S024 | 2007-01-03 | 30-day Notice |
| S023 | 2006-12-07 | 135 Review Track For 30-day Notice |
| S022 | 2006-11-17 | 30-day Notice |
| S021 | 2006-11-07 | 30-day Notice |
| S020 | 2006-10-17 | 30-day Notice |
| S019 | 2006-09-19 | 30-day Notice |
| S018 | 2006-07-24 | 30-day Notice |
| S017 | 2006-06-02 | Special (immediate Track) |
| S016 | 2006-05-09 | 30-day Notice |
| S015 | 2005-11-22 | Normal 180 Day Track No User Fee |
| S014 | 2005-10-28 | Normal 180 Day Track No User Fee |
| S013 | 2005-09-12 | Normal 180 Day Track No User Fee |
| S012 | 2004-11-08 | Normal 180 Day Track No User Fee |
| S011 | 2004-10-19 | Normal 180 Day Track No User Fee |
| S010 | 2004-09-13 | Normal 180 Day Track |
| S009 | 2003-12-08 | 30-day Notice |
| S008 | 2003-03-21 | Real-time Process |
| S007 | 2002-11-01 | Normal 180 Day Track |
| S006 | 2002-06-28 | Normal 180 Day Track |
| S005 | 2002-05-22 | Normal 180 Day Track |
| S004 | 2001-09-17 | Normal 180 Day Track |
| S003 | 2001-08-20 | Normal 180 Day Track |
| S002 | 2001-04-06 | Normal 180 Day Track |
| S001 | 2000-10-17 | Real-time Process |