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 manufacturing and design changes to the catheter tip.
| Device | CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONAL |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | Biosense Webster, Inc |
| Date Received | 2013-11-01 |
| Decision Date | 2014-01-22 |
| PMA | P950005 |
| Supplement | S047 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Biosense Webster, Inc 33 Technology Dr. irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950005 | Original Filing | |
| S085 | 2022-09-02 | 30-day Notice |
| S084 | 2022-06-10 | Normal 180 Day Track |
| S083 | 2021-08-23 | Normal 180 Day Track No User Fee |
| S082 | ||
| S081 | 2021-06-11 | 30-day Notice |
| S080 | ||
| S079 | 2021-04-12 | 30-day Notice |
| S078 | 2021-03-31 | 30-day Notice |
| S077 | 2021-03-02 | Special (immediate Track) |
| S076 | 2021-01-28 | 30-day Notice |
| S075 | 2020-09-15 | 30-day Notice |
| S074 | 2020-03-13 | 30-day Notice |
| S073 | 2020-01-16 | 30-day Notice |
| S072 | 2019-07-30 | 30-day Notice |
| S071 | 2019-02-12 | 30-day Notice |
| S070 | 2018-07-02 | 30-day Notice |
| S069 | 2017-11-27 | 135 Review Track For 30-day Notice |
| S068 | 2017-10-03 | 30-day Notice |
| S067 | 2017-09-11 | 30-day Notice |
| S066 | 2017-06-30 | 30-day Notice |
| S065 | 2017-06-29 | 30-day Notice |
| S064 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S063 | 2016-11-28 | 135 Review Track For 30-day Notice |
| S062 | 2016-08-26 | 30-day Notice |
| S061 | 2016-06-13 | Normal 180 Day Track |
| S060 | 2016-03-31 | 30-day Notice |
| S059 | 2015-10-09 | 30-day Notice |
| S058 | 2015-07-17 | 30-day Notice |
| S057 | 2015-05-06 | 30-day Notice |
| S056 | 2015-02-20 | 30-day Notice |
| S055 | 2014-11-14 | 30-day Notice |
| S054 | 2014-09-29 | Real-time Process |
| S053 | 2014-09-22 | 30-day Notice |
| S052 | 2014-08-14 | 30-day Notice |
| S051 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S050 | 2014-04-03 | 135 Review Track For 30-day Notice |
| S049 | 2013-12-27 | 30-day Notice |
| S048 | 2013-10-18 | 30-day Notice |
| S047 | 2013-11-01 | Real-time Process |
| S046 | 2013-09-13 | 30-day Notice |
| S045 | 2013-08-09 | 30-day Notice |
| S044 | 2013-04-26 | 30-day Notice |
| S043 | 2013-03-27 | 30-day Notice |
| S042 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S041 | 2012-11-07 | Normal 180 Day Track |
| S040 | 2012-09-25 | 30-day Notice |
| S039 | 2012-06-19 | 30-day Notice |
| S038 | 2012-06-19 | Normal 180 Day Track |
| S037 | 2012-04-16 | Normal 180 Day Track |
| S036 | 2011-11-21 | 30-day Notice |
| S035 | 2011-08-29 | 30-day Notice |
| S034 | 2011-03-01 | 30-day Notice |
| S033 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S032 | 2011-01-31 | 30-day Notice |
| S031 | 2010-10-27 | Normal 180 Day Track No User Fee |
| S030 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S029 | 2010-02-12 | 30-day Notice |
| S028 | 2009-09-28 | Real-time Process |
| S027 | ||
| S026 | 2009-04-15 | 30-day Notice |
| S025 | 2009-02-18 | Normal 180 Day Track |
| S024 | 2007-12-14 | Normal 180 Day Track No User Fee |
| S023 | 2007-10-04 | 30-day Notice |
| S022 | 2007-09-28 | Real-time Process |
| S021 | 2007-07-24 | 30-day Notice |
| S020 | 2006-01-26 | 30-day Notice |
| S019 | 2005-09-06 | Normal 180 Day Track |
| S018 | 2004-09-28 | Normal 180 Day Track |
| S017 | 2003-01-02 | Real-time Process |
| S016 | 2002-06-07 | Real-time Process |
| S015 | 2002-04-17 | Normal 180 Day Track |
| S014 | 2001-05-29 | Normal 180 Day Track |
| S013 | 2001-05-23 | Real-time Process |
| S012 | 2001-04-13 | Normal 180 Day Track |
| S011 | 2001-02-21 | Normal 180 Day Track |
| S010 | 2000-12-08 | Normal 180 Day Track |
| S009 | 2000-07-31 | Normal 180 Day Track |
| S008 | 2000-04-19 | Normal 180 Day Track |
| S007 | 1999-11-26 | Real-time Process |
| S006 | 1999-08-02 | |
| S005 | ||
| S004 | 1999-02-22 | Real-time Process |
| S003 | 1998-07-27 | Normal 180 Day Track |
| S002 | 1998-03-23 | Normal 180 Day Track |
| S001 | 1997-11-10 | Normal 180 Day Track |