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.
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names safire blu sp irrigated ablation catheter, therapy cool path sp (bi-directional) ablation catheter, and safire blu duo sp ablation catheter.
| Device | SAFIRE BLU DUO SP ABLATION CATHETERS |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | St. Jude Medical, Inc. (Irvine Biomedical) |
| Date Received | 2012-05-11 |
| Decision Date | 2012-07-10 |
| PMA | P110016 |
| Supplement | S002 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. (Irvine Biomedical) 2375 Morse Avenue irvine, CA 92614-6233 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110016 | Original Filing | |
| S081 | 2022-11-14 | 30-day Notice |
| S080 | ||
| S079 | 2021-09-14 | 30-day Notice |
| S078 | 2021-08-24 | 30-day Notice |
| S077 | 2021-05-26 | 30-day Notice |
| S076 | 2021-04-19 | 30-day Notice |
| S075 | 2021-04-13 | 30-day Notice |
| S074 | 2021-02-25 | 30-day Notice |
| S073 | 2021-01-13 | Real-time Process |
| S072 | 2020-10-28 | Real-time Process |
| S071 | 2020-09-18 | 30-day Notice |
| S070 | ||
| S069 | 2020-05-06 | 30-day Notice |
| S068 | 2020-03-19 | 30-day Notice |
| S067 | ||
| S066 | 2020-02-04 | 30-day Notice |
| S065 | 2019-09-26 | 30-day Notice |
| S064 | 2019-09-12 | Special (immediate Track) |
| S063 | 2019-06-24 | Normal 180 Day Track No User Fee |
| S062 | 2019-04-26 | 30-day Notice |
| S061 | 2019-03-25 | 30-day Notice |
| S060 | 2019-03-15 | 30-day Notice |
| S059 | 2019-02-14 | Normal 180 Day Track No User Fee |
| S058 | 2018-12-12 | Special (immediate Track) |
| S057 | 2018-05-18 | Special (immediate Track) |
| S056 | 2018-03-27 | 30-day Notice |
| S055 | 2018-02-14 | 30-day Notice |
| S054 | 2018-02-12 | 30-day Notice |
| S053 | 2018-02-05 | 30-day Notice |
| S052 | 2017-11-28 | 30-day Notice |
| S051 | 2017-11-02 | 30-day Notice |
| S050 | 2017-10-27 | 135 Review Track For 30-day Notice |
| S049 | 2017-08-22 | 30-day Notice |
| S048 | ||
| S047 | 2017-06-30 | 30-day Notice |
| S046 | 2017-05-04 | 30-day Notice |
| S045 | 2017-04-28 | 30-day Notice |
| S044 | 2017-05-01 | 30-day Notice |
| S043 | 2017-04-28 | 30-day Notice |
| S042 | ||
| S041 | 2017-03-28 | 30-day Notice |
| S040 | 2017-03-20 | 30-day Notice |
| S039 | 2017-03-13 | 30-day Notice |
| S038 | 2017-03-03 | 30-day Notice |
| S037 | ||
| S036 | 2016-09-08 | Special (immediate Track) |
| S035 | 2016-08-12 | 30-day Notice |
| S034 | 2016-06-24 | 135 Review Track For 30-day Notice |
| S033 | 2016-05-27 | 30-day Notice |
| S032 | 2016-05-27 | 30-day Notice |
| S031 | 2016-03-17 | 30-day Notice |
| S030 | 2016-03-14 | 30-day Notice |
| S029 | 2016-02-19 | 30-day Notice |
| S028 | 2015-11-25 | 30-day Notice |
| S027 | 2015-11-20 | Real-time Process |
| S026 | 2015-11-12 | Special (immediate Track) |
| S025 | 2015-11-05 | Normal 180 Day Track |
| S024 | 2015-10-30 | Normal 180 Day Track No User Fee |
| S023 | 2015-09-23 | 30-day Notice |
| S022 | 2015-09-01 | 30-day Notice |
| S021 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S020 | 2015-08-20 | 30-day Notice |
| S019 | ||
| S018 | 2015-06-29 | Special (immediate Track) |
| S017 | 2015-04-20 | 30-day Notice |
| S016 | 2015-02-05 | Normal 180 Day Track No User Fee |
| S015 | 2015-02-04 | Special (immediate Track) |
| S014 | 2014-11-07 | Real-time Process |
| S013 | 2014-06-19 | Normal 180 Day Track |
| S012 | 2014-04-30 | Normal 180 Day Track No User Fee |
| S011 | 2014-03-03 | Real-time Process |
| S010 | 2013-11-27 | Normal 180 Day Track |
| S009 | 2013-08-30 | 30-day Notice |
| S008 | 2013-04-01 | Panel Track |
| S007 | 2013-03-07 | Normal 180 Day Track |
| S006 | 2013-01-24 | Real-time Process |
| S005 | 2012-07-11 | 135 Review Track For 30-day Notice |
| S004 | 2012-07-10 | Real-time Process |
| S003 | 2012-06-25 | Normal 180 Day Track |
| S002 | 2012-05-11 | Real-time Process |
| S001 | 2012-03-29 | 135 Review Track For 30-day Notice |