This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for for the navistar/celsius thermocool deflectable diagnostic/ablation catheters, which include these models: navistar thermocool (models ns75t-bct-252-hs, ns75t-cct-252-hs, ns75t-dct-252-hs, ns75t-fct-252-hs, ns75tc-bct-252-hs, ns75tc-cct-252-hs, ns75tc-dct-252-hs, and ns75tc-fct-252-hs); and celsius thermocool (models d7it-bl-252-rt, d7it-dl-252-rt, d7it-fl-252-rt, d7itc-bl-252-rt, d7itc-dl-252-rt, and d7itc-fl-252-rt). The biosense webster navistar/celsius thermocool diagnostic/ablation deflectable tip catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the stockert 70 generator, for the treatment of type i atrial flutter in patients age 18 or older. The navistar thermocool catheter provides location information when used with the carto ep/xp navigation system.
| Device | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS |
| 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 | 2003-07-28 |
| Decision Date | 2004-11-05 |
| Notice Date | 2004-11-12 |
| PMA | P030031 |
| Supplement | S |
| Product Code | OAD |
| Docket Number | 04M-0497 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030031 | Original Filing | |
| S128 | 2022-09-02 | 30-day Notice |
| S127 | 2022-06-10 | Normal 180 Day Track |
| S126 | ||
| S125 | 2021-10-20 | Real-time Process |
| S124 | 2021-08-23 | Normal 180 Day Track No User Fee |
| S123 | 2021-08-06 | 30-day Notice |
| S122 | ||
| S121 | 2021-06-11 | 30-day Notice |
| S120 | ||
| S119 | ||
| S118 | 2021-04-12 | Normal 180 Day Track No User Fee |
| S117 | 2021-04-12 | 30-day Notice |
| S116 | 2021-03-31 | 30-day Notice |
| S115 | 2021-03-08 | Special (immediate Track) |
| S114 | 2021-03-02 | Special (immediate Track) |
| S113 | 2021-02-23 | 30-day Notice |
| S112 | 2021-01-28 | 30-day Notice |
| S111 | 2021-01-07 | 30-day Notice |
| S110 | ||
| S109 | ||
| S108 | 2020-09-15 | 30-day Notice |
| S107 | 2020-06-25 | 30-day Notice |
| S106 | 2020-06-05 | 30-day Notice |
| S105 | 2020-04-13 | 30-day Notice |
| S104 | 2020-03-13 | 30-day Notice |
| S103 | 2020-03-05 | 30-day Notice |
| S102 | ||
| S101 | 2020-01-16 | 30-day Notice |
| S100 | ||
| S099 | 2019-07-30 | 30-day Notice |
| S098 | ||
| S097 | 2019-04-10 | 30-day Notice |
| S096 | 2019-02-12 | 30-day Notice |
| S095 | ||
| S094 | 2018-12-26 | Real-time Process |
| S093 | 2018-11-05 | Special (immediate Track) |
| S092 | 2018-10-18 | Normal 180 Day Track No User Fee |
| S091 | ||
| S090 | 2018-07-06 | 30-day Notice |
| S089 | 2018-07-02 | 30-day Notice |
| S088 | 2018-06-21 | 30-day Notice |
| S087 | 2017-12-14 | 30-day Notice |
| S086 | 2017-12-04 | Normal 180 Day Track |
| S085 | 2017-10-27 | Normal 180 Day Track No User Fee |
| S084 | 2017-10-03 | 30-day Notice |
| S083 | 2017-09-11 | 30-day Notice |
| S082 | 2017-08-08 | Special (immediate Track) |
| S081 | 2017-06-30 | 30-day Notice |
| S080 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S079 | 2016-10-26 | 30-day Notice |
| S078 | 2016-09-29 | 30-day Notice |
| S077 | 2016-08-26 | 30-day Notice |
| S076 | 2016-08-24 | 30-day Notice |
| S075 | 2016-06-28 | 30-day Notice |
| S074 | 2016-06-13 | Normal 180 Day Track |
| S073 | 2016-03-31 | 30-day Notice |
| S072 | 2016-02-01 | Normal 180 Day Track |
| S071 | 2015-10-09 | 30-day Notice |
| S070 | 2015-07-17 | 30-day Notice |
| S069 | 2015-07-08 | 30-day Notice |
| S068 | 2015-05-06 | 30-day Notice |
| S067 | 2015-02-20 | 30-day Notice |
| S066 | 2015-02-20 | 30-day Notice |
| S065 | 2014-12-10 | Normal 180 Day Track |
| S064 | 2014-11-14 | 30-day Notice |
| S063 | 2014-10-30 | Special (immediate Track) |
| S062 | 2014-09-29 | Real-time Process |
| S061 | 2014-09-15 | 30-day Notice |
| S060 | 2014-08-14 | 30-day Notice |
| S059 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S058 | 2013-12-27 | 30-day Notice |
| S057 | 2013-09-13 | 30-day Notice |
| S056 | ||
| S055 | 2013-08-09 | 30-day Notice |
| S054 | 2013-07-15 | 30-day Notice |
| S053 | 2013-06-17 | Normal 180 Day Track |
| S052 | 2013-04-26 | 30-day Notice |
| S051 | 2013-03-27 | 30-day Notice |
| S050 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S049 | ||
| S048 | 2012-09-25 | 30-day Notice |
| S047 | 2012-08-24 | 30-day Notice |
| S046 | ||
| S045 | 2012-08-03 | Real-time Process |
| S044 | 2012-07-03 | Normal 180 Day Track No User Fee |
| S043 | 2012-06-28 | 30-day Notice |
| S042 | 2012-06-19 | Normal 180 Day Track |
| S041 | 2012-04-16 | Normal 180 Day Track |
| S040 | 2012-03-02 | 30-day Notice |
| S039 | 2012-02-21 | Normal 180 Day Track No User Fee |
| S038 | 2012-01-23 | Real-time Process |
| S037 | 2011-11-21 | 30-day Notice |
| S036 | 2011-10-19 | Real-time Process |
| S035 | 2011-08-29 | 30-day Notice |
| S034 | 2011-06-20 | Normal 180 Day Track |
| S033 | 2011-04-27 | 135 Review Track For 30-day Notice |
| S032 | 2011-03-01 | 30-day Notice |
| S031 | 2011-02-03 | Normal 180 Day Track No User Fee |
| S030 | 2010-06-09 | 30-day Notice |
| S029 | 2010-04-22 | 30-day Notice |
| S028 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S027 | 2010-02-12 | 30-day Notice |
| S026 | 2010-02-05 | 30-day Notice |
| S025 | 2010-01-15 | Normal 180 Day Track |
| S024 | 2010-01-14 | 135 Review Track For 30-day Notice |
| S023 | 2009-12-11 | 135 Review Track For 30-day Notice |
| S022 | 2009-11-17 | Normal 180 Day Track |
| S021 | 2009-10-09 | Real-time Process |
| S020 | 2009-10-06 | Normal 180 Day Track No User Fee |
| S019 | 2009-10-01 | Real-time Process |
| S018 | 2009-09-28 | Real-time Process |
| S017 | ||
| S016 | ||
| S015 | ||
| S014 | 2009-03-06 | Normal 180 Day Track No User Fee |
| S013 | 2008-11-04 | Normal 180 Day Track No User Fee |
| S012 | 2008-10-09 | Special (immediate Track) |
| S011 | 2008-08-13 | Panel Track |
| S010 | 2008-07-11 | Normal 180 Day Track |
| S009 | 2007-11-23 | Normal 180 Day Track |
| S008 | 2007-10-10 | 30-day Notice |
| S007 | 2007-10-04 | 30-day Notice |
| S006 | 2007-09-17 | Normal 180 Day Track No User Fee |
| S005 | 2007-03-30 | Normal 180 Day Track |
| S004 | 2006-12-01 | Real-time Process |
| S003 | 2006-01-26 | 30-day Notice |
| S002 | 2005-09-16 | Normal 180 Day Track No User Fee |
| S001 | 2004-12-17 | Normal 180 Day Track No User Fee |