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 adding remote magnetic navigation technology to the previously approved catheter. The device, as modified, will be marketed under the trade name celsius rmt diagnostic/ablation deflectable tip catheters and is indicated for catheter-based atrial and ventricular electrophysiologic mapping and for use with the stereotaxis magnetic navigation system (mns) and compatible radiofrequency generators in adults and children four (4) years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.
| Device | CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S |
| Classification Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Generic Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Biosense Webster, Inc |
| Date Received | 2004-09-28 |
| Decision Date | 2005-12-16 |
| PMA | P950005 |
| Supplement | S018 |
| Product Code | DRF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Biosense Webster, Inc 33 Technology Dr. irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950005 | Original Filing | |
| S085 | 2022-09-02 | 30-day Notice |
| S084 | 2022-06-10 | Normal 180 Day Track |
| S083 | 2021-08-23 | Normal 180 Day Track No User Fee |
| S082 | ||
| S081 | 2021-06-11 | 30-day Notice |
| S080 | ||
| S079 | 2021-04-12 | 30-day Notice |
| S078 | 2021-03-31 | 30-day Notice |
| S077 | 2021-03-02 | Special (immediate Track) |
| S076 | 2021-01-28 | 30-day Notice |
| S075 | 2020-09-15 | 30-day Notice |
| S074 | 2020-03-13 | 30-day Notice |
| S073 | 2020-01-16 | 30-day Notice |
| S072 | 2019-07-30 | 30-day Notice |
| S071 | 2019-02-12 | 30-day Notice |
| S070 | 2018-07-02 | 30-day Notice |
| S069 | 2017-11-27 | 135 Review Track For 30-day Notice |
| S068 | 2017-10-03 | 30-day Notice |
| S067 | 2017-09-11 | 30-day Notice |
| S066 | 2017-06-30 | 30-day Notice |
| S065 | 2017-06-29 | 30-day Notice |
| S064 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S063 | 2016-11-28 | 135 Review Track For 30-day Notice |
| S062 | 2016-08-26 | 30-day Notice |
| S061 | 2016-06-13 | Normal 180 Day Track |
| S060 | 2016-03-31 | 30-day Notice |
| S059 | 2015-10-09 | 30-day Notice |
| S058 | 2015-07-17 | 30-day Notice |
| S057 | 2015-05-06 | 30-day Notice |
| S056 | 2015-02-20 | 30-day Notice |
| S055 | 2014-11-14 | 30-day Notice |
| S054 | 2014-09-29 | Real-time Process |
| S053 | 2014-09-22 | 30-day Notice |
| S052 | 2014-08-14 | 30-day Notice |
| S051 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S050 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S049 | 2013-12-27 | 30-day Notice |
| S048 | 2013-10-18 | 30-day Notice |
| S047 | 2013-11-01 | Real-time Process |
| S046 | 2013-09-13 | 30-day Notice |
| S045 | 2013-08-09 | 30-day Notice |
| S044 | 2013-04-26 | 30-day Notice |
| S043 | 2013-03-27 | 30-day Notice |
| S042 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S041 | 2012-11-07 | Normal 180 Day Track |
| S040 | 2012-09-25 | 30-day Notice |
| S039 | 2012-06-19 | 30-day Notice |
| S038 | 2012-06-19 | Normal 180 Day Track |
| S037 | 2012-04-16 | Normal 180 Day Track |
| S036 | 2011-11-21 | 30-day Notice |
| S035 | 2011-08-29 | 30-day Notice |
| S034 | 2011-03-01 | 30-day Notice |
| S033 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S032 | 2011-01-31 | 30-day Notice |
| S031 | 2010-10-27 | Normal 180 Day Track No User Fee |
| S030 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S029 | 2010-02-12 | 30-day Notice |
| S028 | 2009-09-28 | Real-time Process |
| S027 | ||
| S026 | 2009-04-15 | 30-day Notice |
| S025 | 2009-02-18 | Normal 180 Day Track |
| S024 | 2007-12-14 | Normal 180 Day Track No User Fee |
| S023 | 2007-10-04 | 30-day Notice |
| S022 | 2007-09-28 | Real-time Process |
| S021 | 2007-07-24 | 30-day Notice |
| S020 | 2006-01-26 | 30-day Notice |
| S019 | 2005-09-06 | Normal 180 Day Track |
| S018 | 2004-09-28 | Normal 180 Day Track |
| S017 | 2003-01-02 | Real-time Process |
| S016 | 2002-06-07 | Real-time Process |
| S015 | 2002-04-17 | Normal 180 Day Track |
| S014 | 2001-05-29 | Normal 180 Day Track |
| S013 | 2001-05-23 | Real-time Process |
| S012 | 2001-04-13 | Normal 180 Day Track |
| S011 | 2001-02-21 | Normal 180 Day Track |
| S010 | 2000-12-08 | Normal 180 Day Track |
| S009 | 2000-07-31 | Normal 180 Day Track |
| S008 | 2000-04-19 | Normal 180 Day Track |
| S007 | 1999-11-26 | Real-time Process |
| S006 | 1999-08-02 | |
| S005 | ||
| S004 | 1999-02-22 | Real-time Process |
| S003 | 1998-07-27 | Normal 180 Day Track |
| S002 | 1998-03-23 | Normal 180 Day Track |
| S001 | 1997-11-10 | Normal 180 Day Track |