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 modification to the currently marketed 1500t9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name ampere generator and is indicated for:the ampere generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias.
| Device | THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | St. Jude Medical, Inc. (Irvine Biomedical) |
| Date Received | 2013-11-27 |
| Decision Date | 2014-03-21 |
| PMA | P110016 |
| Supplement | S010 |
| Product Code | LPB |
| 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 |