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 programmer software modifications (601. U and a-k00. 8. U) for use in biotronik pacemakers and implantable cardioverter defibrillators. The modifications included adding the 1-opt feature, expanding programmer capabilities, improving printing and data import/export capabilities, enhancing communication and memory, updating programmability and ram and correcting software anomalies. The software is for use with epr 1000 plus programming system, tms 1000 plus programming system and ics 3000 implant control system.
| Device | VARIOUS MODELS ICD'S TMS 1000 PLUS |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2006-06-29 |
| Decision Date | 2006-07-26 |
| PMA | P980023 |
| Supplement | S024 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980023 | Original Filing | |
| S118 | 2022-11-30 | Normal 180 Day Track No User Fee |
| S117 | 2022-11-23 | 30-day Notice |
| S116 | 2022-11-10 | 30-day Notice |
| S115 | 2022-09-22 | 30-day Notice |
| S114 | 2022-06-17 | 30-day Notice |
| S113 | ||
| S112 | 2022-02-17 | 30-day Notice |
| S111 | ||
| S110 | 2021-11-23 | 30-day Notice |
| S109 | 2021-09-30 | 30-day Notice |
| S108 | ||
| S107 | 2021-07-21 | 30-day Notice |
| S106 | 2021-06-21 | 30-day Notice |
| S105 | 2021-03-16 | Real-time Process |
| S104 | 2020-11-23 | 30-day Notice |
| S103 | 2020-11-02 | 30-day Notice |
| S102 | 2020-08-10 | Real-time Process |
| S101 | 2020-03-26 | 30-day Notice |
| S100 | ||
| S099 | ||
| S098 | ||
| S097 | 2019-12-31 | 30-day Notice |
| S096 | ||
| S095 | 2019-09-17 | 30-day Notice |
| S094 | 2019-08-15 | Real-time Process |
| S093 | 2019-07-01 | Real-time Process |
| S092 | 2019-04-23 | 30-day Notice |
| S091 | 2019-03-18 | 30-day Notice |
| S090 | 2018-12-11 | Normal 180 Day Track No User Fee |
| S089 | 2018-11-23 | Real-time Process |
| S088 | 2018-11-16 | 30-day Notice |
| S087 | ||
| S086 | 2018-07-10 | 30-day Notice |
| S085 | 2018-06-14 | 135 Review Track For 30-day Notice |
| S084 | 2018-01-22 | 30-day Notice |
| S083 | 2017-11-20 | 30-day Notice |
| S082 | 2017-11-20 | Real-time Process |
| S081 | 2017-04-12 | Real-time Process |
| S080 | 2017-03-07 | 30-day Notice |
| S079 | 2016-11-21 | 30-day Notice |
| S078 | 2016-09-23 | 30-day Notice |
| S077 | 2016-08-01 | 30-day Notice |
| S076 | 2016-06-06 | Normal 180 Day Track |
| S075 | 2016-05-24 | Normal 180 Day Track |
| S074 | 2015-12-23 | Normal 180 Day Track |
| S073 | 2015-08-03 | 30-day Notice |
| S072 | 2015-04-16 | Normal 180 Day Track |
| S071 | 2015-06-19 | Real-time Process |
| S070 | 2015-06-17 | Normal 180 Day Track No User Fee |
| S069 | 2015-06-15 | 30-day Notice |
| S068 | 2015-05-27 | 30-day Notice |
| S067 | 2015-05-22 | 30-day Notice |
| S066 | 2015-04-29 | 135 Review Track For 30-day Notice |
| S065 | 2015-03-06 | 135 Review Track For 30-day Notice |
| S064 | 2015-02-04 | 30-day Notice |
| S063 | 2015-01-08 | 30-day Notice |
| S062 | 2014-09-24 | 30-day Notice |
| S061 | 2014-09-19 | 30-day Notice |
| S060 | 2014-07-28 | Normal 180 Day Track |
| S059 | 2014-06-23 | 30-day Notice |
| S058 | 2014-05-30 | 30-day Notice |
| S057 | 2014-01-27 | Normal 180 Day Track |
| S056 | 2013-06-14 | Real-time Process |
| S055 | 2013-04-29 | 30-day Notice |
| S054 | 2013-04-24 | 135 Review Track For 30-day Notice |
| S053 | 2013-04-22 | 30-day Notice |
| S052 | 2013-04-03 | Real-time Process |
| S051 | 2013-01-14 | 30-day Notice |
| S050 | 2012-12-21 | Real-time Process |
| S049 | 2012-11-14 | Normal 180 Day Track |
| S048 | 2012-09-07 | 30-day Notice |
| S047 | 2012-08-29 | 30-day Notice |
| S046 | 2011-11-14 | Normal 180 Day Track |
| S045 | ||
| S044 | 2011-04-11 | Real-time Process |
| S043 | 2010-12-29 | Real-time Process |
| S042 | ||
| S041 | 2010-05-28 | Normal 180 Day Track No User Fee |
| S040 | 2010-04-13 | 30-day Notice |
| S039 | 2010-02-12 | 30-day Notice |
| S038 | 2009-08-19 | Normal 180 Day Track |
| S037 | 2008-11-20 | Real-time Process |
| S036 | 2008-11-17 | Normal 180 Day Track |
| S035 | 2008-10-31 | Real-time Process |
| S034 | 2008-06-04 | 135 Review Track For 30-day Notice |
| S033 | 2008-05-21 | Real-time Process |
| S032 | 2008-05-14 | Real-time Process |
| S031 | 2008-05-14 | Normal 180 Day Track |
| S030 | 2008-01-07 | Real-time Process |
| S029 | 2007-07-13 | Normal 180 Day Track |
| S028 | 2007-06-25 | 30-day Notice |
| S027 | 2006-12-18 | Real-time Process |
| S026 | 2006-10-12 | Real-time Process |
| S025 | 2006-09-11 | Normal 180 Day Track |
| S024 | 2006-06-29 | Real-time Process |
| S023 | 2006-06-02 | Real-time Process |
| S022 | 2006-04-10 | 135 Review Track For 30-day Notice |
| S021 | 2006-03-10 | Real-time Process |
| S020 | 2005-09-06 | Normal 180 Day Track |
| S019 | 2004-12-19 | Normal 180 Day Track |
| S018 | 2004-06-14 | Real-time Process |
| S017 | 2004-04-02 | Normal 180 Day Track |
| S016 | 2003-09-15 | Real-time Process |
| S015 | 2003-07-16 | Normal 180 Day Track No User Fee |
| S014 | 2003-03-10 | Normal 180 Day Track |
| S013 | 2003-02-19 | Normal 180 Day Track |
| S012 | 2003-01-27 | Normal 180 Day Track |
| S011 | 2002-11-20 | 30-day Notice |
| S010 | 2002-07-22 | Real-time Process |
| S009 | 2002-06-04 | Normal 180 Day Track |
| S008 | 2002-04-08 | Real-time Process |
| S007 | 2002-01-22 | Normal 180 Day Track |
| S006 | 2002-02-04 | Real-time Process |
| S005 | 2001-06-25 | Normal 180 Day Track |
| S004 | 2001-04-27 | Normal 180 Day Track |
| S003 | 1999-11-02 | Normal 180 Day Track |
| S002 | 1999-06-01 | Real-time Process |
| S001 | 1999-02-22 | Real-time Process |