CHILLI COOLED RF ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Premarket Approval P980003

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.

Pre-market Approval Supplement Details

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.

DeviceCHILLI COOLED RF ABLATION SYSTEM
Classification NameCardiac Ablation Percutaneous Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBoston Scientific Corp.
Date Received1998-01-30
Decision Date1999-02-02
Notice Date1999-06-28
PMAP980003
SupplementS
Product CodeLPB
Docket Number99M-2016
Advisory CommitteeCardiovascular
Expedited ReviewYes
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

Supplemental Filings

Supplement NumberDateSupplement Type
P980003Original 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

Device IDPMASupp
08714729767152 P980003 000
08714729454816 P980003 000
08714729454533 P980003 000
08714729452850 P980003 000
08714729452843 P980003 000
08714729452805 P980003 000
08714729347897 P980003 000
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.