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 adding a mediguide technology passive sensor into the tip of the device for the purposes of aiding navigation and changing the cool path duo uni-directional (uni-d) handle to a cool path duo bi-directional (bi-d) handle. The devices, as modified, will be marketed under the trade names cool path duo ablation catheter, mediguide enabled and safire duo ablation catheter, mediguide enabled and are indicated for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter. The catheters are intended for use with a compatible external pump and the ibi-1500t9-cp rf generator at a maximum of 50 watts. Mediguide enabled ablation catheters are used with the mediguide technology to enable real-time tip positioning and navigation. The mediguide technology is indicated for use as an adjunct to fluoroscopy.
| Device | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER |
| 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 | 2012-06-25 |
| Decision Date | 2013-07-30 |
| PMA | P110016 |
| Supplement | S003 |
| 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 | 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 |