Approval for modifications mad to the navistar ds 8mm tip deflectable diagnostic/ablation catheter approved under p010068 and the qwikstar 4 mm deflectable tip diagnostic/ablation catheter approved under p990025/s004. The device, as modified, will be marketed under the trade name qwikstar ds diagnostic/ablation catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulation and recording) and when used with the stockert 70 rf generator (software version 1. 033 or higher) for the treatment of type i atrial flutter in patients 18 years or older.
| Device | QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2003-11-03 |
| Decision Date | 2004-01-14 |
| PMA | P010068 |
| Supplement | S002 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |
|---|
| P010068 | | 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 |
2018-07-02 |
30-day Notice |
| S056 |
2017-10-03 |
30-day Notice |
| S055 |
2017-09-11 |
30-day Notice |
| S054 |
2017-06-30 |
30-day Notice |
| S053 |
2017-06-02 |
135 Review Track For 30-day Notice |
| S052 |
2016-08-26 |
30-day Notice |
| S051 |
2016-06-13 |
Normal 180 Day Track |
| S050 |
2016-03-31 |
30-day Notice |
| S049 |
2015-10-09 |
30-day Notice |
| S048 |
2015-07-17 |
30-day Notice |
| S047 |
2015-05-06 |
30-day Notice |
| S046 |
2015-02-20 |
30-day Notice |
| S045 |
2015-02-20 |
30-day Notice |
| S044 |
2014-11-14 |
30-day Notice |
| S043 |
2014-09-29 |
Real-time Process |
| S042 |
2014-09-22 |
30-day Notice |
| S041 |
2014-08-14 |
30-day Notice |
| S040 |
2014-07-02 |
Normal 180 Day Track No User Fee |
| S039 |
2014-04-03 |
135 Review Track For 30-day Notice |
| S038 |
2013-12-27 |
30-day Notice |
| S037 |
2013-10-18 |
30-day Notice |
| S036 |
2013-11-01 |
Real-time Process |
| S035 |
2013-08-09 |
30-day Notice |
| S034 |
2013-04-26 |
30-day Notice |
| S033 |
2013-03-27 |
30-day Notice |
| S032 |
2013-03-21 |
135 Review Track For 30-day Notice |
| S031 |
2012-11-07 |
Normal 180 Day Track |
| S030 |
2012-09-25 |
30-day Notice |
| S029 |
2012-06-19 |
30-day Notice |
| S028 |
2012-06-19 |
Normal 180 Day Track |
| S027 |
2012-04-16 |
Normal 180 Day Track |
| S026 |
2012-03-02 |
30-day Notice |
| S025 |
2011-08-29 |
30-day Notice |
| S024 |
2011-03-01 |
30-day Notice |
| S023 |
2011-03-01 |
135 Review Track For 30-day Notice |
| S022 |
2011-01-31 |
30-day Notice |
| S021 |
2010-10-27 |
Normal 180 Day Track No User Fee |
| S020 |
2010-03-02 |
Normal 180 Day Track No User Fee |
| S019 |
2010-02-05 |
30-day Notice |
| S018 |
2009-10-09 |
Real-time Process |
| S017 |
2009-09-28 |
Real-time Process |
| S016 | | |
| S015 | | |
| S014 |
2009-04-15 |
30-day Notice |
| S013 |
2008-10-09 |
Special (immediate Track) |
| S012 |
2007-12-14 |
Normal 180 Day Track No User Fee |
| S011 |
2007-10-04 |
30-day Notice |
| S010 |
2007-07-31 |
30-day Notice |
| S009 |
2006-01-31 |
Normal 180 Day Track |
| S008 |
2006-01-26 |
30-day Notice |
| S007 |
2005-09-22 |
Normal 180 Day Track No User Fee |
| S006 |
2005-09-06 |
Normal 180 Day Track |
| S005 |
2004-11-03 |
Normal 180 Day Track No User Fee |
| S004 |
2004-07-28 |
Real-time Process |
| S003 |
2004-03-11 |
Normal 180 Day Track No User Fee |
| S002 |
2003-11-03 |
Real-time Process |
| S001 |
2003-01-02 |
Real-time Process |
NIH GUDID Devices