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.
Approval for a manufacturing site located at sterigenics, in los angeles, california as an alternate sterilization site.
Device | EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH |
Classification Name | Cardiac Ablation Percutaneous Catheter |
Generic Name | Cardiac Ablation Percutaneous Catheter |
Applicant | BIOSENSE WEBSTER, INC. |
Date Received | 2014-07-02 |
Decision Date | 2015-12-17 |
PMA | P040036 |
Supplement | S044 |
Product Code | LPB |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618 |
Supplement Number | Date | Supplement Type |
---|---|---|
P040036 | Original Filing | |
S090 | 2022-09-02 | 30-day Notice |
S089 | 2022-06-10 | Normal 180 Day Track |
S088 | ||
S087 | 2021-10-20 | Real-time Process |
S086 | 2021-08-23 | Normal 180 Day Track No User Fee |
S085 | 2021-08-06 | 30-day Notice |
S084 | ||
S083 | 2021-06-11 | 30-day Notice |
S082 | ||
S081 | 2021-04-12 | 30-day Notice |
S080 | 2021-03-31 | 30-day Notice |
S079 | 2021-03-02 | Special (immediate Track) |
S078 | 2021-02-23 | 30-day Notice |
S077 | 2021-01-28 | 30-day Notice |
S076 | 2021-01-07 | 30-day Notice |
S075 | 2020-06-25 | 30-day Notice |
S074 | 2020-06-05 | 30-day Notice |
S073 | 2020-04-13 | 30-day Notice |
S072 | 2020-03-13 | 30-day Notice |
S071 | 2020-03-05 | 30-day Notice |
S070 | ||
S069 | 2020-01-16 | 30-day Notice |
S068 | 2019-07-30 | 30-day Notice |
S067 | 2019-04-10 | 30-day Notice |
S066 | 2019-02-12 | 30-day Notice |
S065 | ||
S064 | 2018-12-26 | Real-time Process |
S063 | 2018-07-06 | 30-day Notice |
S062 | 2017-12-14 | 30-day Notice |
S061 | 2017-10-03 | 30-day Notice |
S060 | 2017-08-08 | Special (immediate Track) |
S059 | 2017-06-30 | 30-day Notice |
S058 | 2017-06-02 | 135 Review Track For 30-day Notice |
S057 | 2016-08-26 | 30-day Notice |
S056 | 2016-06-28 | 30-day Notice |
S055 | 2016-06-13 | Normal 180 Day Track |
S054 | 2016-03-31 | 30-day Notice |
S053 | 2015-10-09 | 30-day Notice |
S052 | 2015-07-17 | 30-day Notice |
S051 | 2015-07-08 | 30-day Notice |
S050 | 2015-02-20 | 30-day Notice |
S049 | 2015-02-20 | 30-day Notice |
S048 | 2014-12-10 | Normal 180 Day Track |
S047 | 2014-10-30 | Special (immediate Track) |
S046 | 2014-09-29 | Real-time Process |
S045 | 2014-08-14 | 30-day Notice |
S044 | 2014-07-02 | Normal 180 Day Track No User Fee |
S043 | 2014-05-23 | Normal 180 Day Track No User Fee |
S042 | ||
S041 | 2013-12-27 | 30-day Notice |
S040 | 2013-09-13 | 30-day Notice |
S039 | 2013-08-09 | 30-day Notice |
S038 | 2013-07-15 | 30-day Notice |
S037 | 2013-06-17 | Normal 180 Day Track |
S036 | 2013-04-26 | 30-day Notice |
S035 | 2013-03-27 | 30-day Notice |
S034 | ||
S033 | 2013-03-21 | 135 Review Track For 30-day Notice |
S032 | 2012-07-03 | Normal 180 Day Track No User Fee |
S031 | 2012-06-19 | Normal 180 Day Track |
S030 | 2012-04-16 | Normal 180 Day Track |
S029 | 2012-03-02 | 30-day Notice |
S028 | 2011-11-21 | 30-day Notice |
S027 | 2011-10-19 | Real-time Process |
S026 | 2011-08-29 | 30-day Notice |
S025 | ||
S024 | 2011-04-27 | 135 Review Track For 30-day Notice |
S023 | 2011-03-01 | 30-day Notice |
S022 | 2010-04-22 | 30-day Notice |
S021 | 2010-03-02 | Normal 180 Day Track No User Fee |
S020 | 2010-02-12 | 30-day Notice |
S019 | 2010-02-05 | 30-day Notice |
S018 | ||
S017 | 2010-01-14 | 135 Review Track For 30-day Notice |
S016 | 2009-12-11 | 135 Review Track For 30-day Notice |
S015 | 2009-11-17 | Normal 180 Day Track |
S014 | 2009-10-09 | Real-time Process |
S013 | 2009-09-28 | Real-time Process |
S012 | ||
S011 | ||
S010 | ||
S009 | 2008-10-09 | Special (immediate Track) |
S008 | 2008-07-11 | Normal 180 Day Track |
S007 | 2008-07-01 | Normal 180 Day Track No User Fee |
S006 | 2007-11-23 | Normal 180 Day Track |
S005 | 2007-10-10 | 30-day Notice |
S004 | 2007-10-04 | 30-day Notice |
S003 | 2007-03-30 | Normal 180 Day Track |
S002 | 2006-12-01 | Real-time Process |
S001 | 2006-10-19 | Normal 180 Day Track No User Fee |