To reduce the ethylene oxide gas concentration and qualify additional process challenge devices used in the bsc2000-2 sterilization cycle
| Device | Chilli II Cooled Ablation Catheter and Cable |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | Boston Scientific Corp. |
| Date Received | 2019-10-10 |
| Decision Date | 2019-11-07 |
| PMA | P980003 |
| Supplement | S091 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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