Approval for: 1) use of a compatible radiofrequency (rf) generator for delivery of rf energy through the tip of the chilli cooled ablation catheter and the addition of accessories to connect the catheter to the rf generator; 2) a temperature sensor converter (model 2067 thermocouple to thermistor translator (ttt) module) for the thermocouple output of the chilli cooled ablation catheter to the thermistor input of the compatible rf generator; and 3) a separate, compatible pump (model 8005 pump system) for delivery of fluid flow through the tip of the chilli/cooled ablation catheter and a new tubing kit accessory (model 2104 sterile disposable tube set) which connects the catheter to the pump.
Device | CHILLI COOLED ABLATION SYSTEM |
Classification Name | Cardiac Ablation Percutaneous Catheter |
Generic Name | Cardiac Ablation Percutaneous Catheter |
Applicant | Boston Scientific Corp. |
Date Received | 2002-04-09 |
Decision Date | 2002-06-28 |
PMA | P980003 |
Supplement | S005 |
Product Code | LPB |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 |
Supplemental Filings
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 |
NIH GUDID Devices