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 packaging design change for the blazer ii/prime htd catheters electrophysiology cables, models m0046130 and m0046510; chilli cooled ablation system electrophysiology cables, models m0046810 and m004620620; and blazer ii xp and blazer prime cardiac ablation catheters electrophysiology cables, models m0046130 and m0046510.
Device | CHILLI II CATHETER |
Classification Name | Cardiac Ablation Percutaneous Catheter |
Generic Name | Cardiac Ablation Percutaneous Catheter |
Applicant | Boston Scientific Corp. |
Date Received | 2011-06-09 |
Decision Date | 2011-07-19 |
PMA | P980003 |
Supplement | S029 |
Product Code | LPB |
Advisory Committee | Cardiovascular |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 |
Supplement Number | Date | Supplement Type |
---|---|---|
P980003 | Original Filing | |
S094 | 2022-10-17 | 30-day Notice |
S093 | 2022-01-28 | 30-day Notice |
S092 | 2020-03-12 | Normal 180 Day Track No User Fee |
S091 | 2019-10-10 | 30-day Notice |
S090 | 2019-08-09 | 30-day Notice |
S089 | 2019-04-08 | 30-day Notice |
S088 | 2018-08-24 | 30-day Notice |
S087 | 2018-06-21 | Normal 180 Day Track |
S086 | 2018-06-13 | 30-day Notice |
S085 | 2018-04-06 | 135 Review Track For 30-day Notice |
S084 | 2018-01-17 | 30-day Notice |
S083 | 2017-10-30 | 30-day Notice |
S082 | 2017-10-02 | 30-day Notice |
S081 | 2017-09-15 | 30-day Notice |
S080 | 2017-09-14 | 30-day Notice |
S079 | 2017-08-30 | 30-day Notice |
S078 | 2017-08-04 | 30-day Notice |
S077 | 2017-07-18 | 30-day Notice |
S076 | 2017-06-26 | 30-day Notice |
S075 | 2017-05-18 | 30-day Notice |
S074 | 2017-04-27 | Real-time Process |
S073 | 2017-04-13 | 30-day Notice |
S072 | 2017-03-06 | 30-day Notice |
S071 | 2016-11-09 | 30-day Notice |
S070 | ||
S069 | 2016-07-21 | 30-day Notice |
S068 | 2016-07-21 | 30-day Notice |
S067 | ||
S066 | 2016-04-15 | 135 Review Track For 30-day Notice |
S065 | 2016-02-12 | 30-day Notice |
S064 | 2015-09-10 | 30-day Notice |
S063 | 2015-08-18 | Special (immediate Track) |
S062 | 2015-07-20 | 30-day Notice |
S061 | 2015-06-29 | Normal 180 Day Track No User Fee |
S060 | ||
S059 | 2015-04-29 | 30-day Notice |
S058 | 2015-04-13 | 30-day Notice |
S057 | 2015-03-12 | 30-day Notice |
S056 | 2015-01-13 | Real-time Process |
S055 | 2014-11-19 | 30-day Notice |
S054 | 2014-09-29 | 30-day Notice |
S053 | 2014-06-13 | Normal 180 Day Track No User Fee |
S052 | 2014-06-10 | Normal 180 Day Track |
S051 | 2014-06-02 | 30-day Notice |
S050 | 2014-05-05 | Normal 180 Day Track No User Fee |
S049 | 2014-03-31 | 30-day Notice |
S048 | 2014-03-28 | 30-day Notice |
S047 | 2014-02-24 | 30-day Notice |
S046 | 2014-01-14 | 30-day Notice |
S045 | 2013-10-31 | Special (immediate Track) |
S044 | ||
S043 | 2013-09-23 | 30-day Notice |
S042 | 2013-09-19 | 30-day Notice |
S041 | 2013-09-09 | Special (immediate Track) |
S040 | 2013-08-29 | 30-day Notice |
S039 | 2013-08-07 | 30-day Notice |
S038 | 2013-07-05 | Real-time Process |
S037 | 2012-11-19 | 30-day Notice |
S036 | 2012-04-27 | 30-day Notice |
S035 | 2012-03-23 | 30-day Notice |
S034 | 2011-12-27 | Real-time Process |
S033 | 2011-11-07 | 30-day Notice |
S032 | 2011-10-11 | 30-day Notice |
S031 | 2011-09-19 | Real-time Process |
S030 | 2011-06-21 | Normal 180 Day Track No User Fee |
S029 | 2011-06-09 | |
S028 | 2011-03-23 | 135 Review Track For 30-day Notice |
S027 | 2010-11-23 | Real-time Process |
S026 | 2010-10-29 | 30-day Notice |
S025 | 2010-10-18 | Normal 180 Day Track |
S024 | 2010-10-07 | 135 Review Track For 30-day Notice |
S023 | ||
S022 | 2010-01-26 | 30-day Notice |
S021 | 2008-04-23 | Normal 180 Day Track |
S020 | 2007-09-27 | Special (immediate Track) |
S019 | 2007-05-10 | Real-time Process |
S018 | 2007-03-12 | Normal 180 Day Track No User Fee |
S017 | 2006-05-16 | 30-day Notice |
S016 | 2005-07-18 | Normal 180 Day Track |
S015 | 2005-03-16 | Real-time Process |
S014 | 2005-01-31 | 30-day Notice |
S013 | 2004-08-30 | Real-time Process |
S012 | 2004-01-14 | 30-day Notice |
S011 | 2003-12-08 | 30-day Notice |
S010 | 2003-11-03 | Normal 180 Day Track No User Fee |
S009 | 2003-10-02 | Real-time Process |
S008 | 2003-06-20 | Normal 180 Day Track No User Fee |
S007 | 2003-05-14 | Normal 180 Day Track |
S006 | ||
S005 | 2002-04-09 | Normal 180 Day Track |
S004 | 2001-12-26 | Normal 180 Day Track |
S003 | ||
S002 | 1999-04-14 | Real-time Process |
S001 | 1999-03-03 | Normal 180 Day Track |