The addition of warnings from other catheter lines and the clarification of existing warnings and instructions
| Device | Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2021-03-02 |
| Decision Date | 2021-04-07 |
| PMA | P010068 |
| Supplement | S062 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 31 Technology Drive suite 200 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