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 the tachos dr atrial tx implantable cardioverter defibrillator (icd) system, model 122499 with software cartridge swm / i-kdr. 0. C, model 339684. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The device is indicated for use in icd patients with either atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias.
| Device | TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2002-03-22 |
| Decision Date | 2002-09-09 |
| Notice Date | 2007-11-09 |
| PMA | P000009 |
| Supplement | S004 |
| Product Code | MRM |
| Docket Number | 07M-0408 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000009 | Original Filing | |
| S100 | 2022-11-15 | Real-time Process |
| S099 | 2022-11-10 | 30-day Notice |
| S098 | 2022-06-17 | 30-day Notice |
| S097 | 2022-02-07 | Real-time Process |
| S096 | ||
| S095 | ||
| S094 | 2021-07-21 | 30-day Notice |
| S093 | 2021-06-21 | 30-day Notice |
| S092 | ||
| S091 | 2021-05-05 | 30-day Notice |
| S090 | 2021-03-16 | Real-time Process |
| S089 | 2020-11-23 | 30-day Notice |
| S088 | 2020-11-02 | 30-day Notice |
| S087 | 2020-08-10 | Real-time Process |
| S086 | ||
| S085 | 2020-03-26 | 30-day Notice |
| S084 | ||
| S083 | ||
| S082 | ||
| S081 | 2019-08-15 | Real-time Process |
| S080 | 2019-07-01 | Real-time Process |
| S079 | 2019-03-11 | Real-time Process |
| S078 | 2018-09-12 | Normal 180 Day Track |
| S077 | 2018-08-22 | Real-time Process |
| S076 | 2018-05-17 | Real-time Process |
| S075 | 2017-10-18 | Real-time Process |
| S074 | 2017-06-06 | Real-time Process |
| S073 | ||
| S072 | 2017-04-20 | Real-time Process |
| S071 | 2017-02-16 | Normal 180 Day Track |
| S070 | 2016-12-07 | Normal 180 Day Track |
| S069 | 2016-08-08 | Normal 180 Day Track |
| S068 | 2016-07-28 | Normal 180 Day Track |
| S067 | 2016-06-06 | Normal 180 Day Track |
| S066 | 2016-03-24 | Real-time Process |
| S065 | 2015-12-23 | Normal 180 Day Track |
| S064 | 2015-12-16 | Real-time Process |
| S063 | 2015-04-16 | Normal 180 Day Track |
| S062 | 2015-03-23 | Normal 180 Day Track |
| S061 | 2015-02-13 | Real-time Process |
| S060 | 2014-09-25 | Normal 180 Day Track |
| S059 | 2014-09-24 | 30-day Notice |
| S058 | 2014-06-23 | Normal 180 Day Track |
| S057 | 2013-11-25 | Normal 180 Day Track |
| S056 | 2013-11-07 | Real-time Process |
| S055 | 2013-08-15 | Real-time Process |
| S054 | 2013-04-03 | Real-time Process |
| S053 | ||
| S052 | 2012-12-21 | Real-time Process |
| S051 | 2012-12-18 | Normal 180 Day Track |
| S050 | 2012-07-02 | Real-time Process |
| S049 | 2012-03-01 | Normal 180 Day Track |
| S048 | 2012-02-17 | Real-time Process |
| S047 | 2011-11-02 | Normal 180 Day Track |
| S046 | 2011-08-19 | Normal 180 Day Track |
| S045 | 2011-04-11 | Real-time Process |
| S044 | ||
| S043 | 2010-12-13 | Real-time Process |
| S042 | 2010-10-28 | Normal 180 Day Track |
| S041 | 2010-08-20 | 30-day Notice |
| S040 | 2010-06-08 | Normal 180 Day Track |
| S039 | 2010-05-28 | Normal 180 Day Track No User Fee |
| S038 | 2009-11-25 | Real-time Process |
| S037 | ||
| S036 | 2009-09-10 | Real-time Process |
| S035 | 2009-07-08 | Normal 180 Day Track |
| S034 | 2009-02-13 | Real-time Process |
| S033 | 2009-01-26 | Normal 180 Day Track |
| S032 | 2008-11-17 | Normal 180 Day Track |
| S031 | 2008-10-31 | Real-time Process |
| S030 | 2008-09-25 | 135 Review Track For 30-day Notice |
| S029 | 2008-07-03 | 135 Review Track For 30-day Notice |
| S028 | 2008-05-21 | Real-time Process |
| S027 | ||
| S026 | 2008-05-14 | Normal 180 Day Track |
| S025 | 2008-01-15 | Real-time Process |
| S024 | 2007-10-26 | Normal 180 Day Track |
| S023 | 2007-08-13 | Normal 180 Day Track |
| S022 | 2007-07-13 | Normal 180 Day Track |
| S021 | 2006-10-12 | Real-time Process |
| S020 | 2006-09-11 | Normal 180 Day Track |
| S019 | 2006-06-29 | Real-time Process |
| S018 | 2006-04-10 | 135 Review Track For 30-day Notice |
| S017 | 2006-03-10 | Real-time Process |
| S016 | 2005-06-16 | Real-time Process |
| S015 | 2005-03-18 | Real-time Process |
| S014 | 2005-01-24 | Real-time Process |
| S013 | 2004-08-27 | Real-time Process |
| S012 | 2004-04-12 | Real-time Process |
| S011 | 2004-03-03 | Real-time Process |
| S010 | 2003-09-29 | Real-time Process |
| S009 | 2003-07-03 | Normal 180 Day Track |
| S008 | 2003-02-10 | Normal 180 Day Track |
| S007 | 2002-12-19 | Normal 180 Day Track |
| S006 | 2002-11-20 | 30-day Notice |
| S005 | 2002-09-25 | Real-time Process |
| S004 | 2002-03-22 | Panel Track |
| S003 | 2002-01-18 | Real-time Process |
| S002 | 2001-08-10 | Real-time Process |
| S001 | 2000-12-13 | Normal 180 Day Track |