Chilli II Cooled Ablation Catheter and Cable

Cardiac Ablation Percutaneous Catheter

FDA Premarket Approval P980003 S091

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.

Pre-market Approval Supplement Details

To reduce the ethylene oxide gas concentration and qualify additional process challenge devices used in the bsc2000-2 sterilization cycle

DeviceChilli II Cooled Ablation Catheter and Cable
Classification NameCardiac Ablation Percutaneous Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBoston Scientific Corp.
Date Received2019-10-10
Decision Date2019-11-07
Product CodeLPB
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement NumberDateSupplement Type
P980003Original Filing
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
S069 2016-07-21 30-day Notice
S068 2016-07-21 30-day Notice
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
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)
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
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
S005 2002-04-09 Normal 180 Day Track
S004 2001-12-26 Normal 180 Day Track
S002 1999-04-14 Real-time Process
S001 1999-03-03 Normal 180 Day Track

© 2019
This site is not affiliated with or endorsed by the FDA.