Approval for minor design changes to the outer shell of the upper and lower handle components.
| Device | SAFIRE BIDIRECTIONAL ABLATION CATHETER |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | St. Jude Medical |
| Date Received | 2007-10-03 |
| Decision Date | 2007-12-19 |
| PMA | P960016 |
| Supplement | S020 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 14900 Minnetonka Ind Rd minnetonka, MN 55345 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960016 | | Original Filing |
| S089 |
2022-11-14 |
30-day Notice |
| S088 |
2021-09-14 |
30-day Notice |
| S087 | | |
| S086 |
2021-01-13 |
Real-time Process |
| S085 |
2020-09-18 |
30-day Notice |
| S084 | | |
| S083 |
2020-05-06 |
30-day Notice |
| S082 |
2020-03-23 |
30-day Notice |
| S081 |
2020-03-19 |
30-day Notice |
| S080 |
2019-09-26 |
30-day Notice |
| S079 |
2019-06-24 |
Normal 180 Day Track No User Fee |
| S078 |
2019-04-26 |
30-day Notice |
| S077 |
2019-02-14 |
Normal 180 Day Track No User Fee |
| S076 |
2018-12-12 |
Special (immediate Track) |
| S075 |
2018-08-02 |
30-day Notice |
| S074 |
2018-03-05 |
30-day Notice |
| S073 |
2018-03-01 |
30-day Notice |
| S072 |
2018-02-12 |
30-day Notice |
| S071 |
2018-02-05 |
30-day Notice |
| S070 |
2017-10-19 |
30-day Notice |
| S069 | | |
| S068 |
2017-05-04 |
30-day Notice |
| S067 |
2016-08-12 |
30-day Notice |
| S066 |
2016-06-01 |
30-day Notice |
| S065 |
2016-04-21 |
30-day Notice |
| S064 |
2016-03-22 |
135 Review Track For 30-day Notice |
| S063 |
2016-03-14 |
30-day Notice |
| S062 |
2016-03-09 |
30-day Notice |
| S061 |
2016-02-19 |
30-day Notice |
| S060 |
2015-11-20 |
Real-time Process |
| S059 |
2015-10-30 |
Normal 180 Day Track No User Fee |
| S058 |
2015-10-19 |
30-day Notice |
| S057 |
2015-09-23 |
30-day Notice |
| S056 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S055 |
2015-06-25 |
Normal 180 Day Track |
| S054 |
2015-04-17 |
30-day Notice |
| S053 |
2015-03-06 |
30-day Notice |
| S052 |
2014-12-22 |
Special (immediate Track) |
| S051 |
2014-12-17 |
Real-time Process |
| S050 |
2014-11-07 |
Real-time Process |
| S049 |
2014-08-27 |
Real-time Process |
| S048 |
2014-08-06 |
Special (immediate Track) |
| S047 |
2014-07-01 |
Real-time Process |
| S046 |
2014-04-30 |
Normal 180 Day Track No User Fee |
| S045 |
2014-03-03 |
Real-time Process |
| S044 |
2013-11-27 |
Normal 180 Day Track |
| S043 |
2013-09-19 |
135 Review Track For 30-day Notice |
| S042 |
2013-02-04 |
135 Review Track For 30-day Notice |
| S041 |
2013-02-01 |
135 Review Track For 30-day Notice |
| S040 |
2012-12-17 |
Real-time Process |
| S039 |
2012-07-23 |
Real-time Process |
| S038 |
2011-11-22 |
30-day Notice |
| S037 |
2011-07-05 |
30-day Notice |
| S036 |
2010-11-10 |
30-day Notice |
| S035 |
2010-10-05 |
30-day Notice |
| S034 |
2010-09-30 |
Real-time Process |
| S033 |
2010-09-27 |
Real-time Process |
| S032 |
2010-08-12 |
30-day Notice |
| S031 |
2010-07-20 |
30-day Notice |
| S030 |
2010-07-14 |
30-day Notice |
| S029 |
2010-05-27 |
Special (immediate Track) |
| S028 |
2010-03-09 |
30-day Notice |
| S027 |
2009-10-30 |
30-day Notice |
| S026 |
2009-10-29 |
30-day Notice |
| S025 |
2009-10-28 |
30-day Notice |
| S024 |
2009-09-02 |
30-day Notice |
| S023 | | |
| S022 |
2008-01-28 |
Real-time Process |
| S021 | | |
| S020 |
2007-10-03 |
Real-time Process |
| S019 |
2007-08-07 |
Real-time Process |
| S018 |
2007-04-26 |
Real-time Process |
| S017 | | |
| S016 |
2006-04-07 |
Real-time Process |
| S015 | | |
| S014 |
2005-09-09 |
Normal 180 Day Track |
| S013 |
2003-09-10 |
Special (immediate Track) |
| S012 |
2003-07-15 |
Real-time Process |
| S011 |
2003-06-26 |
135 Review Track For 30-day Notice |
| S010 |
2003-03-05 |
Normal 180 Day Track |
| S009 |
2003-02-12 |
Real-time Process |
| S008 |
2002-08-08 |
Real-time Process |
| S007 |
2001-05-14 |
Normal 180 Day Track |
| S006 |
2000-08-22 |
Normal 180 Day Track |
| S005 |
2000-08-18 |
Normal 180 Day Track |
| S004 |
2000-03-30 |
Normal 180 Day Track |
| S003 |
1999-06-28 |
Normal 180 Day Track |
| S002 |
1999-05-20 |
Normal 180 Day Track |
| S001 |
1999-05-06 |
Real-time Process |
NIH GUDID Devices