Change in calibration and calibration check manufacturing processes pi-008-01 and pi-008-02 to incorporate the catheter calibration system as an alternative to the helmholtz calibration system.
Device | NAVISTAR DS ELECTROPHYSIOLOGY 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 | 2012-03-02 |
Decision Date | 2012-03-30 |
PMA | P010068 |
Supplement | S026 |
Product Code | OAD |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
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