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.
Change to the manufacturing process equipment by implementing an alternate bioslide coating machine, with updated hardware, software, and processing changes, as well as a minor rearrangement of the existing production equipment to new locations within the current manufacturing line.
| Device | CORONARY FLEXTOME CUTTING BALLOON |
| Applicant | Boston Scientific Corp. |
| Date Received | 2011-11-04 |
| Decision Date | 2011-12-07 |
| PMA | P950020 |
| Supplement | S047 |
| 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 |
|---|---|---|
| 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 |