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.
Alternate vendor to manufacture the tube braid component used for the intellanav xp and intellanav mifi xp temperature ablation catheters.
| Device | IntellaNav XP and IntellaNav 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 | 2017-06-08 |
| Decision Date | 2017-06-27 |
| PMA | P020025 |
| Supplement | S102 |
| Product Code | OAD |
| 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 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 |