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.
Approval for five changes to address the failure of a micro switch designed to automatically shut off the pump if the roller bed cover is opened without turning off the power switch. These changes include: 1) introducing a new micro switch which features an auxiliary actuator which eliminates direct contact between the retainer screw and the actuator button; 2) adding a secondary shoulder on the retainer screw to limit the screw penetration depth to coincide with the tolerance stack up with the micro switch position; 3) minor dimension and tolerance changes to the mounting plate to accommodate the new micro switch; 4) use counter-sink holes instead of straight-through holes in the pump head to secure the mounting plate, ensuring bracket alignment and minimizing play in the bracket installation; and 5) adding an inspection step and test fixture to verify the installed position of the micro switch relative to the pump head.
Device | CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP |
Classification Name | Cardiac Ablation Percutaneous Catheter |
Generic Name | Cardiac Ablation Percutaneous Catheter |
Applicant | Boston Scientific Corp. |
Date Received | 2011-12-27 |
Decision Date | 2012-02-15 |
PMA | P980003 |
Supplement | S034 |
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 |
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 |