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 | NAVISTAR |
| Generic Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF 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 | P990025 |
| Supplement | S069 |
| Product Code | DRF |
| 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 NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF 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 |
|---|---|---|
| P990025 | 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 | 2019-02-12 | 30-day Notice |
| S056 | 2018-07-02 | 30-day Notice |
| S055 | 2017-10-03 | 30-day Notice |
| S054 | 2017-09-11 | 30-day Notice |
| S053 | 2017-06-30 | 30-day Notice |
| S052 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S051 | 2016-11-28 | 135 Review Track For 30-day Notice |
| S050 | 2016-08-26 | 30-day Notice |
| S049 | 2016-06-13 | Normal 180 Day Track |
| S048 | 2016-03-31 | 30-day Notice |
| S047 | 2015-10-09 | 30-day Notice |
| S046 | 2015-05-06 | 30-day Notice |
| S045 | 2015-02-20 | 30-day Notice |
| S044 | 2015-02-20 | 30-day Notice |
| S043 | 2014-11-14 | 30-day Notice |
| S042 | 2014-09-29 | Real-time Process |
| S041 | 2014-09-22 | 30-day Notice |
| S040 | 2014-07-02 | Normal 180 Day Track No User Fee |
| S039 | 2013-12-27 | 30-day Notice |
| S038 | 2013-08-09 | 30-day Notice |
| S037 | 2013-04-26 | 30-day Notice |
| S036 | 2013-03-27 | 30-day Notice |
| S035 | 2013-03-21 | 135 Review Track For 30-day Notice |
| S034 | 2012-09-25 | 30-day Notice |
| S033 | 2012-06-19 | 30-day Notice |
| S032 | 2012-06-19 | Normal 180 Day Track |
| S031 | 2012-04-16 | Normal 180 Day Track |
| S030 | 2012-03-02 | 30-day Notice |
| S029 | 2011-08-29 | 30-day Notice |
| S028 | 2011-03-01 | 30-day Notice |
| S027 | 2011-01-31 | 30-day Notice |
| S026 | 2010-10-27 | Normal 180 Day Track No User Fee |
| S025 | 2010-03-02 | Normal 180 Day Track No User Fee |
| S024 | 2010-02-12 | 30-day Notice |
| S023 | 2010-02-05 | 30-day Notice |
| S022 | 2009-10-09 | Real-time Process |
| S021 | 2009-09-28 | Real-time Process |
| S020 | ||
| S019 | ||
| S018 | 2009-04-15 | 30-day Notice |
| S017 | 2009-02-18 | Normal 180 Day Track |
| S016 | 2008-10-09 | Special (immediate Track) |
| S015 | 2007-12-14 | Normal 180 Day Track No User Fee |
| S014 | 2007-10-04 | 30-day Notice |
| S013 | 2007-07-31 | 30-day Notice |
| S012 | 2006-06-14 | Normal 180 Day Track |
| S011 | 2006-01-18 | Real-time Process |
| S010 | 2006-01-26 | 30-day Notice |
| S009 | 2005-04-27 | Normal 180 Day Track |
| S008 | 2003-01-02 | Real-time Process |
| S007 | 2002-08-23 | Normal 180 Day Track |
| S006 | 2002-06-07 | Real-time Process |
| S005 | 2002-04-17 | Normal 180 Day Track |
| S004 | 2002-04-01 | Normal 180 Day Track |
| S003 | 2000-12-21 | 30-day Notice |
| S002 | 2000-12-11 | Normal 180 Day Track |
| S001 | 2000-07-31 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 10846835000214 | P990025 | 000 |
| 10846835001990 | P990025 | 000 |
| 10846835001983 | P990025 | 000 |
| 10846835001976 | P990025 | 000 |
| 10846835001969 | P990025 | 000 |
| 10846835001952 | P990025 | 000 |
| 10846835001914 | P990025 | 000 |
| 10846835001907 | P990025 | 000 |
| 10846835001891 | P990025 | 000 |
| 10846835000610 | P990025 | 000 |
| 10846835000597 | P990025 | 000 |
| 10846835008555 | P990025 | 000 |
| 10846835000207 | P990025 | 000 |
| 10846835008586 | P990025 | 000 |
| 10846835008531 | P990025 | 000 |
| 10846835008579 | P990025 | 000 |
| 10846835008562 | P990025 | 000 |
| 10846835008470 | P990025 | 009 |
| 10846835008463 | P990025 | 009 |
| 10846835003017 | P990025 | 012 |
| 10846835003055 | P990025 | 012 |
| 10846835002973 | P990025 | 012 |
| 10846835003031 | P990025 | 012 |
| 10846835002997 | P990025 | 012 |