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 a design change to system cables from lead containingsolder to lead-free solder.
| Device | BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2015-01-13 |
| Decision Date | 2015-04-06 |
| PMA | P020025 |
| Supplement | S067 |
| Product Code | OAD |
| 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 150 Baytech Drive san Jose, CA 95134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020025 | Original Filing | |
| S137 | 2022-10-17 | 30-day Notice |
| S136 | 2022-08-22 | 30-day Notice |
| S135 | 2022-01-28 | 30-day Notice |
| S134 | 2022-01-24 | 30-day Notice |
| S133 | 2021-08-13 | 30-day Notice |
| S132 | 2021-05-19 | Real-time Process |
| S131 | ||
| S130 | 2021-03-11 | Normal 180 Day Track No User Fee |
| S129 | ||
| S128 | 2020-05-21 | 30-day Notice |
| S127 | 2020-03-30 | Real-time Process |
| S126 | 2020-03-12 | Normal 180 Day Track No User Fee |
| S125 | 2020-01-22 | 30-day Notice |
| S124 | 2020-01-15 | 30-day Notice |
| S123 | 2019-11-22 | Real-time Process |
| S122 | 2019-10-10 | 30-day Notice |
| S121 | 2019-08-09 | 30-day Notice |
| S120 | 2019-04-12 | Real-time Process |
| S119 | 2019-04-08 | 30-day Notice |
| S118 | ||
| S117 | 2019-03-21 | 30-day Notice |
| S116 | 2018-10-30 | 30-day Notice |
| S115 | 2018-10-25 | 135 Review Track For 30-day Notice |
| S114 | 2018-08-24 | 30-day Notice |
| S113 | 2018-06-21 | Normal 180 Day Track |
| S112 | 2018-06-13 | 30-day Notice |
| S111 | 2018-04-06 | 135 Review Track For 30-day Notice |
| S110 | 2018-01-17 | 30-day Notice |
| S109 | 2017-10-30 | 30-day Notice |
| S108 | 2017-10-02 | 30-day Notice |
| S107 | 2017-09-14 | 30-day Notice |
| S106 | 2017-08-30 | 30-day Notice |
| S105 | 2017-08-04 | 30-day Notice |
| S104 | 2017-07-18 | 30-day Notice |
| S103 | 2017-06-26 | 30-day Notice |
| S102 | 2017-06-08 | 30-day Notice |
| S101 | 2017-04-27 | Real-time Process |
| S100 | 2017-04-13 | 30-day Notice |
| S099 | 2017-04-07 | 30-day Notice |
| S098 | 2017-03-29 | Real-time Process |
| S097 | 2017-03-06 | 30-day Notice |
| S096 | 2017-03-03 | Real-time Process |
| S095 | 2017-02-16 | Normal 180 Day Track No User Fee |
| S094 | 2017-01-05 | Real-time Process |
| S093 | 2016-11-22 | 30-day Notice |
| S092 | 2016-11-09 | 30-day Notice |
| S091 | 2016-09-01 | 135 Review Track For 30-day Notice |
| S090 | 2016-07-21 | 30-day Notice |
| S089 | ||
| S088 | 2016-05-11 | Real-time Process |
| S087 | 2016-04-15 | 135 Review Track For 30-day Notice |
| S086 | 2016-03-24 | 30-day Notice |
| S085 | 2016-03-24 | 30-day Notice |
| S084 | 2016-02-12 | 30-day Notice |
| S083 | 2016-02-12 | 30-day Notice |
| S082 | 2015-11-20 | 135 Review Track For 30-day Notice |
| S081 | 2015-11-19 | 30-day Notice |
| S080 | 2015-09-10 | 30-day Notice |
| S079 | 2015-09-03 | 30-day Notice |
| S078 | 2015-08-18 | Special (immediate Track) |
| S077 | 2015-07-24 | Normal 180 Day Track |
| S076 | 2015-06-29 | Normal 180 Day Track No User Fee |
| S075 | 2015-06-23 | Real-time Process |
| S074 | 2015-06-12 | Special (immediate Track) |
| S073 | ||
| S072 | 2015-05-13 | 30-day Notice |
| S071 | 2015-04-29 | 30-day Notice |
| S070 | 2015-04-28 | 30-day Notice |
| S069 | 2015-04-13 | 30-day Notice |
| S068 | 2015-03-12 | 30-day Notice |
| S067 | 2015-01-13 | Real-time Process |
| S066 | 2014-12-17 | 30-day Notice |
| S065 | 2014-11-19 | 30-day Notice |
| S064 | 2014-09-22 | 30-day Notice |
| S063 | 2014-06-30 | 30-day Notice |
| S062 | 2014-06-16 | 30-day Notice |
| S061 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S060 | 2014-06-10 | Normal 180 Day Track |
| S059 | 2014-05-05 | Normal 180 Day Track No User Fee |
| S058 | 2014-04-30 | 30-day Notice |
| S057 | 2014-03-31 | 30-day Notice |
| S056 | 2014-03-28 | 30-day Notice |
| S055 | 2014-03-04 | 30-day Notice |
| S054 | 2014-02-24 | 30-day Notice |
| S053 | 2014-01-14 | 30-day Notice |
| S052 | 2014-01-09 | 30-day Notice |
| S051 | 2013-11-21 | 30-day Notice |
| S050 | 2013-11-04 | 30-day Notice |
| S049 | 2013-10-31 | Special (immediate Track) |
| S048 | 2013-09-23 | 30-day Notice |
| S047 | 2013-09-19 | 30-day Notice |
| S046 | 2013-09-12 | Real-time Process |
| S045 | 2013-09-12 | Real-time Process |
| S044 | 2013-09-09 | Special (immediate Track) |
| S043 | 2013-08-29 | 30-day Notice |
| S042 | 2013-07-15 | 30-day Notice |
| S041 | ||
| S040 | 2013-03-21 | 30-day Notice |
| S039 | 2013-03-04 | 30-day Notice |
| S038 | 2013-01-24 | 30-day Notice |
| S037 | 2012-12-26 | 30-day Notice |
| S036 | 2012-11-02 | Normal 180 Day Track |
| S035 | 2012-09-05 | 30-day Notice |
| S034 | 2012-04-27 | 30-day Notice |
| S033 | 2012-03-23 | 30-day Notice |
| S032 | 2011-11-07 | 30-day Notice |
| S031 | 2011-09-19 | Real-time Process |
| S030 | 2011-07-20 | 30-day Notice |
| S029 | 2011-06-21 | Normal 180 Day Track No User Fee |
| S028 | 2011-06-09 | |
| S027 | 2011-03-23 | 135 Review Track For 30-day Notice |
| S026 | 2011-02-28 | Normal 180 Day Track No User Fee |
| S025 | 2010-10-07 | 135 Review Track For 30-day Notice |
| S024 | 2010-07-27 | 30-day Notice |
| S023 | 2010-05-27 | 30-day Notice |
| S022 | 2010-01-26 | 30-day Notice |
| S021 | 2009-06-03 | Normal 180 Day Track No User Fee |
| S020 | 2009-04-06 | Normal 180 Day Track |
| S019 | 2007-03-12 | Normal 180 Day Track No User Fee |
| S018 | 2006-09-21 | Real-time Process |
| S017 | 2006-05-16 | 30-day Notice |
| S016 | ||
| S015 | 2005-10-13 | Normal 180 Day Track No User Fee |
| S014 | 2005-09-22 | Normal 180 Day Track No User Fee |
| S013 | 2005-09-06 | 30-day Notice |
| S012 | 2005-07-18 | Normal 180 Day Track |
| S011 | 2005-05-19 | Real-time Process |
| S010 | 2005-01-24 | Real-time Process |
| S009 | ||
| S008 | 2004-12-17 | 30-day Notice |
| S007 | 2004-09-15 | 30-day Notice |
| S006 | 2004-05-26 | Real-time Process |
| S005 | 2004-05-24 | Normal 180 Day Track No User Fee |
| S004 | 2003-12-18 | Normal 180 Day Track |
| S003 | 2003-12-08 | 30-day Notice |
| S002 | 2003-11-03 | Normal 180 Day Track No User Fee |
| S001 | 2003-09-24 | Normal 180 Day Track |