Approval for modified catheter designs to the 7fr celsius and 7fr ez steer ds catheters to create the 7. 5fr 8 mm celsius fltr catheters. The changes being approved are the increased distal profile, larger curve profile, increased range of deflection, and increased deflectable tip diameter. The devices, as modified, will be marketed under the trade names bi-directional celsius fltr catheters (d-1359-xx-s) and uni-directional celsius fltr catheters (d-1355-xx-s) and are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and when used with the stockert 70 (with software version 001/033 or higher) for the treatment of type i atrial flutter in patients age 18 years of age or older.
| Device | UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S) |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2012-11-07 |
| Decision Date | 2013-06-06 |
| PMA | P010068 |
| Supplement | S031 |
| Product Code | OAD |
| 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 |
|---|
| 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