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 the chili(r) cooled ablation system which includes: 1)chili(r) cooled ablation catheter, standard curve (model 3005; 2)chili(r) cooled ablation catheter, large curve (model 3006); rf generator/pump system (model 8004); egm bypass switch box (model 2035); rf filter box (model 2048); chili(r) tubing kit (model 2100); egm/rf generator cable (models 2001 and 2028); and egm generator cable (model 2002 and 2029). This device is indicated for cardiac electropysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.
Device | CHILLI COOLED RF ABLATION SYSTEM |
Classification Name | Cardiac Ablation Percutaneous Catheter |
Generic Name | Cardiac Ablation Percutaneous Catheter |
Applicant | Boston Scientific Corp. |
Date Received | 1998-01-30 |
Decision Date | 1999-02-02 |
Notice Date | 1999-06-28 |
PMA | P980003 |
Supplement | S |
Product Code | LPB |
Docket Number | 99M-2016 |
Advisory Committee | Cardiovascular |
Expedited Review | Yes |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 |
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 |
---|---|---|
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 |