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 blazer prime xp catheter design modifications, material packaging, labeling changes, and addition of accessories: intellatip mifi cable, filter module, and reference cable for the intellatip mifi family of catheters. The device, as modified, will be marketed under the trade name intellatip mifi xp ablation catheter and is indicated for use with the bsc maestro 3000 cardiac ablation controller and accessories for the treatment of sustained or recurrent type i atrial flutter in patients age 18 or older. The bsc high power cardiac ablation controller and accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
| Device | INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER |
| 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 | 2012-11-02 |
| Decision Date | 2013-08-07 |
| PMA | P020025 |
| Supplement | S036 |
| Product Code | OAD |
| 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 | Normal 180 Day Track |
| 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 |