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.
| Device | Chilli II Cooled Catheter, Sterile Cables, Tubing Kit |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP980003 Supplement NumberS093 Date Received01/28/2022 Decision Date02/25/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-01-28 |
| Decision Date | 2022-02-25 |
| PMA | P980003 |
| Supplement | S093 |
| 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 PMA NumberP980003 Supplement NumberS093 Date Received01/28/2022 Decision Date02/25/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Introduction Of Parametric Release For The BSC2000-2 Ethylene Oxide Sterilization Cycle At The BSC Coventry, RI Facility |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729767152 | P980003 | 000 |
| 08714729454816 | P980003 | 000 |
| 08714729454533 | P980003 | 000 |
| 08714729452850 | P980003 | 000 |
| 08714729452843 | P980003 | 000 |
| 08714729452805 | P980003 | 000 |
| 08714729347897 | P980003 | 000 |