Approval for adding remote magnetic navigation technology to the previously approved catheter. The device, as modified, will be marketed under the trade name navistar rmt diagnostic/ablation steerable tip catheter 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. When used with the cargo? Ep navigation system, the navistar rmt catheter provides location information.
| Device | NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2005-04-27 |
| Decision Date | 2006-01-26 |
| PMA | P990025 |
| Supplement | S009 |
| Product Code | LPB |
| 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 Drive irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990025 | | Original Filing |
| S070 |
2022-09-02 |
30-day Notice |
| S069 |
2022-06-10 |
Normal 180 Day Track |
| S068 |
2021-08-23 |
Normal 180 Day Track No User Fee |
| S067 | | |
| S066 |
2021-06-11 |
30-day Notice |
| S065 | | |
| S064 |
2021-04-12 |
30-day Notice |
| S063 |
2021-03-31 |
30-day Notice |
| S062 |
2021-03-02 |
Special (immediate Track) |
| S061 |
2021-01-28 |
30-day Notice |
| S060 |
2020-09-15 |
30-day Notice |
| S059 |
2020-03-13 |
30-day Notice |
| S058 |
2020-01-16 |
30-day Notice |
| S057 |
2019-02-12 |
30-day Notice |
| S056 |
2018-07-02 |
30-day Notice |
| S055 |
2017-10-03 |
30-day Notice |
| S054 |
2017-09-11 |
30-day Notice |
| S053 |
2017-06-30 |
30-day Notice |
| S052 |
2017-06-02 |
135 Review Track For 30-day Notice |
| S051 |
2016-11-28 |
135 Review Track For 30-day Notice |
| S050 |
2016-08-26 |
30-day Notice |
| S049 |
2016-06-13 |
Normal 180 Day Track |
| S048 |
2016-03-31 |
30-day Notice |
| S047 |
2015-10-09 |
30-day Notice |
| S046 |
2015-05-06 |
30-day Notice |
| S045 |
2015-02-20 |
30-day Notice |
| S044 |
2015-02-20 |
30-day Notice |
| S043 |
2014-11-14 |
30-day Notice |
| S042 |
2014-09-29 |
Real-time Process |
| S041 |
2014-09-22 |
30-day Notice |
| S040 |
2014-07-02 |
Normal 180 Day Track No User Fee |
| S039 |
2013-12-27 |
30-day Notice |
| S038 |
2013-08-09 |
30-day Notice |
| S037 |
2013-04-26 |
30-day Notice |
| S036 |
2013-03-27 |
30-day Notice |
| S035 |
2013-03-21 |
135 Review Track For 30-day Notice |
| S034 |
2012-09-25 |
30-day Notice |
| S033 |
2012-06-19 |
30-day Notice |
| S032 |
2012-06-19 |
Normal 180 Day Track |
| S031 |
2012-04-16 |
Normal 180 Day Track |
| S030 |
2012-03-02 |
30-day Notice |
| S029 |
2011-08-29 |
30-day Notice |
| S028 |
2011-03-01 |
30-day Notice |
| S027 |
2011-01-31 |
30-day Notice |
| S026 |
2010-10-27 |
Normal 180 Day Track No User Fee |
| S025 |
2010-03-02 |
Normal 180 Day Track No User Fee |
| S024 |
2010-02-12 |
30-day Notice |
| S023 |
2010-02-05 |
30-day Notice |
| S022 |
2009-10-09 |
Real-time Process |
| S021 |
2009-09-28 |
Real-time Process |
| S020 | | |
| S019 | | |
| S018 |
2009-04-15 |
30-day Notice |
| S017 |
2009-02-18 |
Normal 180 Day Track |
| S016 |
2008-10-09 |
Special (immediate Track) |
| S015 |
2007-12-14 |
Normal 180 Day Track No User Fee |
| S014 |
2007-10-04 |
30-day Notice |
| S013 |
2007-07-31 |
30-day Notice |
| S012 |
2006-06-14 |
Normal 180 Day Track |
| S011 |
2006-01-18 |
Real-time Process |
| S010 |
2006-01-26 |
30-day Notice |
| S009 |
2005-04-27 |
Normal 180 Day Track |
| S008 |
2003-01-02 |
Real-time Process |
| S007 |
2002-08-23 |
Normal 180 Day Track |
| S006 |
2002-06-07 |
Real-time Process |
| S005 |
2002-04-17 |
Normal 180 Day Track |
| S004 |
2002-04-01 |
Normal 180 Day Track |
| S003 |
2000-12-21 |
30-day Notice |
| S002 |
2000-12-11 |
Normal 180 Day Track |
| S001 |
2000-07-31 |
Normal 180 Day Track |
NIH GUDID Devices