Approval for a minor labeling revision for the 4 mm qwikstar diagnostic/ablation catheter to include the noga xp navigation system as an optional mapping system for the qwikstar catheter. The device, as modified, will be marketed under the same trade name and is indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radio-frequency generators in adults and children four years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used in the carto xp ep or noga xp navigation systems, the qwikstar diagnostic/ablation catheter provides location information and approximate catheter tip curvature.
| Device | QWIKSTAR NAVIGATION/ABLATION CATHETER |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2006-01-18 |
| Decision Date | 2006-03-28 |
| PMA | P990025 |
| Supplement | S011 |
| 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 |
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