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.
| Device | Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS128 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-02 |
| Decision Date | 2022-09-30 |
| PMA | P030031 |
| Supplement | S128 |
| 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 PMA NumberP030031 Supplement NumberS128 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add An Additional Chamber For The Sterilization Of Catheters And Cables At The Isomedix Operation, Inc. (Steris Grand Prairie) Facility In Grand Prairie, Texas |
| 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 |