This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
The implementation of an automated dimensional inspection process for the ring spacing, tip length, and shaft outer diameter
| Device | Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2021-01-28 |
| Decision Date | 2021-02-02 |
| PMA | P030031 |
| Supplement | S112 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 31 Technology Drive suite 200 irvine, CA 92618 |
| 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 |