Approval for two additional quality control inspection steps: 1) adding a 100% visual inspection of the pcb boards to verify that all components are present, and 2) adding an eeprom read step during the existing calibration process to verify that all pcb components are present and functioning properly.
| Device | NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2008-10-09 |
| Decision Date | 2008-11-07 |
| PMA | P990025 |
| Supplement | S016 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| 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 |
|---|
| 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 |
NIH GUDID Devices