Approval for changes made to the internal distal tip configuration and the catheter shaft as well as changes in the manufacturing process to bond the steering mechanism to the braided shaft for the chilli ii cardiac ablation catheter.
| Device | CHILLI II COOLED ABLATION CATHETER |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | Boston Scientific Corp. |
| Date Received | 2004-08-30 |
| Decision Date | 2004-10-14 |
| PMA | P980003 |
| Supplement | S013 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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