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 | 8mm Dual Sensor (DS) Catheters |
Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Applicant | BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
Date Received | 2022-06-10 |
Decision Date | 2022-09-09 |
PMA | P010068 |
Supplement | S069 |
Product Code | OAD |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOSENSE WEBSTER, INC. 31 Technology Drive suite 200 irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement software And Hardware Modifications For The NGEN Generator (compatible With The THERMOCOOL, NAVISTAR, And CELSIUS Catheters) |
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 |
Device ID | PMA | Supp |
---|---|---|
10846835003680 | P010068 | 000 |
10846835000399 | P010068 | 000 |
10846835000580 | P010068 | 000 |
10846835000603 | P010068 | 000 |
10846835000627 | P010068 | 000 |
10846835003697 | P010068 | 000 |
10846835006094 | P010068 | 000 |
10846835006124 | P010068 | 000 |
10846835006148 | P010068 | 000 |
10846835006193 | P010068 | 000 |
10846835008524 | P010068 | 000 |
10846835003666 | P010068 | 000 |
10846835003406 | P010068 | 000 |
10846835008548 | P010068 | 000 |
10846835000191 | P010068 | 000 |
10846835000184 | P010068 | 000 |
10846835002980 | P010068 | 006 |
10846835003000 | P010068 | 006 |
10846835003024 | P010068 | 006 |
10846835003048 | P010068 | 006 |
10846835003062 | P010068 | 006 |
10846835013078 | P010068 | 031 |
10846835013061 | P010068 | 031 |
10846835018080 | P010068 | 067 |