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 changes in labeling to remove a statement excluding use with the stereotaxis cardiodrive catheter advancement system.
| Device | NAVISTAR RMT THERMOCOOL |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2009-09-28 |
| Decision Date | 2009-11-25 |
| PMA | P040036 |
| Supplement | S013 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040036 | Original Filing | |
| S090 | 2022-09-02 | 30-day Notice |
| S089 | 2022-06-10 | Normal 180 Day Track |
| S088 | ||
| S087 | 2021-10-20 | Real-time Process |
| S086 | 2021-08-23 | Normal 180 Day Track No User Fee |
| S085 | 2021-08-06 | 30-day Notice |
| S084 | ||
| S083 | 2021-06-11 | 30-day Notice |
| S082 | ||
| S081 | 2021-04-12 | 30-day Notice |
| S080 | 2021-03-31 | 30-day Notice |
| S079 | 2021-03-02 | Special (immediate Track) |
| S078 | 2021-02-23 | 30-day Notice |
| S077 | 2021-01-28 | 30-day Notice |
| S076 | 2021-01-07 | 30-day Notice |
| S075 | 2020-06-25 | 30-day Notice |
| S074 | 2020-06-05 | 30-day Notice |
| S073 | 2020-04-13 | 30-day Notice |
| S072 | 2020-03-13 | 30-day Notice |
| S071 | 2020-03-05 | 30-day Notice |
| S070 | ||
| S069 | 2020-01-16 | 30-day Notice |
| S068 | 2019-07-30 | 30-day Notice |
| S067 | 2019-04-10 | 30-day Notice |
| S066 | 2019-02-12 | 30-day Notice |
| S065 | ||
| S064 | 2018-12-26 | Real-time Process |
| S063 | 2018-07-06 | 30-day Notice |
| S062 | 2017-12-14 | 30-day Notice |
| S061 | 2017-10-03 | 30-day Notice |
| S060 | 2017-08-08 | Special (immediate Track) |
| S059 | 2017-06-30 | 30-day Notice |
| S058 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S057 | 2016-08-26 | 30-day Notice |
| S056 | 2016-06-28 | 30-day Notice |
| S055 | 2016-06-13 | Normal 180 Day Track |
| S054 | 2016-03-31 | 30-day Notice |
| S053 | 2015-10-09 | 30-day Notice |
| S052 | 2015-07-17 | 30-day Notice |
| S051 | 2015-07-08 | 30-day Notice |
| S050 | 2015-02-20 | 30-day Notice |
| S049 | 2015-02-20 | 30-day Notice |
| S048 | 2014-12-10 | Normal 180 Day Track |
| S047 | 2014-10-30 | Special (immediate Track) |
| S046 | 2014-09-29 | Real-time Process |
| S045 | 2014-08-14 | 30-day Notice |
| S044 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S043 | 2014-05-23 | Normal 180 Day Track No User Fee |
| S042 | ||
| S041 | 2013-12-27 | 30-day Notice |
| S040 | 2013-09-13 | 30-day Notice |
| S039 | 2013-08-09 | 30-day Notice |
| S038 | 2013-07-15 | 30-day Notice |
| S037 | 2013-06-17 | Normal 180 Day Track |
| S036 | 2013-04-26 | 30-day Notice |
| S035 | 2013-03-27 | 30-day Notice |
| S034 | ||
| S033 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S032 | 2012-07-03 | Normal 180 Day Track No User Fee |
| S031 | 2012-06-19 | Normal 180 Day Track |
| S030 | 2012-04-16 | Normal 180 Day Track |
| S029 | 2012-03-02 | 30-day Notice |
| S028 | 2011-11-21 | 30-day Notice |
| S027 | 2011-10-19 | Real-time Process |
| S026 | 2011-08-29 | 30-day Notice |
| S025 | ||
| S024 | 2011-04-27 | 135 Review Track For 30-day Notice |
| S023 | 2011-03-01 | 30-day Notice |
| S022 | 2010-04-22 | 30-day Notice |
| S021 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S020 | 2010-02-12 | 30-day Notice |
| S019 | 2010-02-05 | 30-day Notice |
| S018 | ||
| S017 | 2010-01-14 | 135 Review Track For 30-day Notice |
| S016 | 2009-12-11 | 135 Review Track For 30-day Notice |
| S015 | 2009-11-17 | Normal 180 Day Track |
| S014 | 2009-10-09 | Real-time Process |
| S013 | 2009-09-28 | Real-time Process |
| S012 | ||
| S011 | ||
| S010 | ||
| S009 | 2008-10-09 | Special (immediate Track) |
| S008 | 2008-07-11 | Normal 180 Day Track |
| S007 | 2008-07-01 | Normal 180 Day Track No User Fee |
| S006 | 2007-11-23 | Normal 180 Day Track |
| S005 | 2007-10-10 | 30-day Notice |
| S004 | 2007-10-04 | 30-day Notice |
| S003 | 2007-03-30 | Normal 180 Day Track |
| S002 | 2006-12-01 | Real-time Process |
| S001 | 2006-10-19 | Normal 180 Day Track No User Fee |