Increasing the range of the final chamber temperature during dynamic conditioning, lowering the minimum load temperature during the ethylene oxide (eo) dwell phase, and changing of the measurement period when measuring eo concentration during the eo dwell phase.
| Device | CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER, |
| 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 | 2013-08-09 |
| Decision Date | 2013-09-05 |
| PMA | P010068 |
| Supplement | S035 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010068 | | Original Filing |
| S070 |
2022-09-02 |
30-day Notice |
| S069 |
2022-06-10 |
Normal 180 Day Track |
| S068 |
2021-08-23 |
Normal 180 Day Track No User Fee |
| S067 | | |
| S066 |
2021-06-11 |
30-day Notice |
| S065 | | |
| S064 |
2021-04-12 |
30-day Notice |
| S063 |
2021-03-31 |
30-day Notice |
| S062 |
2021-03-02 |
Special (immediate Track) |
| S061 |
2021-01-28 |
30-day Notice |
| S060 |
2020-09-15 |
30-day Notice |
| S059 |
2020-03-13 |
30-day Notice |
| S058 |
2020-01-16 |
30-day Notice |
| S057 |
2018-07-02 |
30-day Notice |
| S056 |
2017-10-03 |
30-day Notice |
| S055 |
2017-09-11 |
30-day Notice |
| S054 |
2017-06-30 |
30-day Notice |
| S053 |
2017-06-02 |
135 Review Track For 30-day Notice |
| S052 |
2016-08-26 |
30-day Notice |
| S051 |
2016-06-13 |
Normal 180 Day Track |
| S050 |
2016-03-31 |
30-day Notice |
| S049 |
2015-10-09 |
30-day Notice |
| S048 |
2015-07-17 |
30-day Notice |
| S047 |
2015-05-06 |
30-day Notice |
| S046 |
2015-02-20 |
30-day Notice |
| S045 |
2015-02-20 |
30-day Notice |
| S044 |
2014-11-14 |
30-day Notice |
| S043 |
2014-09-29 |
Real-time Process |
| S042 |
2014-09-22 |
30-day Notice |
| S041 |
2014-08-14 |
30-day Notice |
| S040 |
2014-07-02 |
Normal 180 Day Track No User Fee |
| S039 |
2014-04-03 |
135 Review Track For 30-day Notice |
| S038 |
2013-12-27 |
30-day Notice |
| S037 |
2013-10-18 |
30-day Notice |
| S036 |
2013-11-01 |
Real-time Process |
| S035 |
2013-08-09 |
30-day Notice |
| S034 |
2013-04-26 |
30-day Notice |
| S033 |
2013-03-27 |
30-day Notice |
| S032 |
2013-03-21 |
135 Review Track For 30-day Notice |
| S031 |
2012-11-07 |
Normal 180 Day Track |
| S030 |
2012-09-25 |
30-day Notice |
| S029 |
2012-06-19 |
30-day Notice |
| S028 |
2012-06-19 |
Normal 180 Day Track |
| S027 |
2012-04-16 |
Normal 180 Day Track |
| S026 |
2012-03-02 |
30-day Notice |
| S025 |
2011-08-29 |
30-day Notice |
| S024 |
2011-03-01 |
30-day Notice |
| S023 |
2011-03-01 |
135 Review Track For 30-day Notice |
| S022 |
2011-01-31 |
30-day Notice |
| S021 |
2010-10-27 |
Normal 180 Day Track No User Fee |
| S020 |
2010-03-02 |
Normal 180 Day Track No User Fee |
| S019 |
2010-02-05 |
30-day Notice |
| S018 |
2009-10-09 |
Real-time Process |
| S017 |
2009-09-28 |
Real-time Process |
| S016 | | |
| S015 | | |
| S014 |
2009-04-15 |
30-day Notice |
| S013 |
2008-10-09 |
Special (immediate Track) |
| S012 |
2007-12-14 |
Normal 180 Day Track No User Fee |
| S011 |
2007-10-04 |
30-day Notice |
| S010 |
2007-07-31 |
30-day Notice |
| S009 |
2006-01-31 |
Normal 180 Day Track |
| S008 |
2006-01-26 |
30-day Notice |
| S007 |
2005-09-22 |
Normal 180 Day Track No User Fee |
| S006 |
2005-09-06 |
Normal 180 Day Track |
| S005 |
2004-11-03 |
Normal 180 Day Track No User Fee |
| S004 |
2004-07-28 |
Real-time Process |
| S003 |
2004-03-11 |
Normal 180 Day Track No User Fee |
| S002 |
2003-11-03 |
Real-time Process |
| S001 |
2003-01-02 |
Real-time Process |
NIH GUDID Devices