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 merging the labeling for the two approved indications for the navistar thermocool diagnostic/ablation catheters (atrial flutter under p030031, and ventricular tachycardia under p040036) and updating the labeling for the celsius thermocool which remains approved for treatment of atrial flutter only.
| Device | NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2006-12-01 |
| Decision Date | 2007-04-23 |
| PMA | P040036 |
| Supplement | S002 |
| 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 |