Approval for the addition of models 500/540 to the lumax family of icd/crt-dsand ics 3000 programmer. These models would contain:¿ a third programmable cardioversion / defibrillation shock pathway to offer moreprogramming options¿ automatic threshold measurement (atm) feature ¿ electronic module (hardware) updates to support the third programmable shock path¿ modifications to the litronik batteries to increase capacity¿ new standard value of the programmable pacing pulse width¿ updated ram firmware to support new features
| Device | STRATOS LV/LV-T |
| Classification Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2008-05-15 |
| Decision Date | 2008-11-04 |
| PMA | P070008 |
| Supplement | S001 |
| Product Code | NKE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P070008 | | Original Filing |
| S143 |
2022-11-15 |
Real-time Process |
| S142 |
2022-11-10 |
30-day Notice |
| S141 |
2022-10-18 |
30-day Notice |
| S140 |
2022-09-22 |
30-day Notice |
| S139 |
2022-08-29 |
30-day Notice |
| S138 |
2022-08-03 |
30-day Notice |
| S137 |
2022-06-17 |
30-day Notice |
| S136 |
2022-02-07 |
Real-time Process |
| S135 |
2022-02-01 |
30-day Notice |
| S134 | | |
| S133 |
2021-11-24 |
30-day Notice |
| S132 |
2021-09-30 |
30-day Notice |
| S131 | | |
| S130 | | |
| S129 |
2021-08-05 |
30-day Notice |
| S128 |
2021-07-21 |
30-day Notice |
| S127 |
2021-06-21 |
30-day Notice |
| S126 | | |
| S125 |
2021-05-05 |
30-day Notice |
| S124 |
2021-05-04 |
30-day Notice |
| S123 |
2021-03-18 |
30-day Notice |
| S122 | | |
| S121 |
2020-11-23 |
30-day Notice |
| S120 |
2020-11-02 |
30-day Notice |
| S119 |
2020-10-28 |
30-day Notice |
| S118 | | |
| S117 |
2020-08-10 |
Real-time Process |
| S116 | | |
| S115 |
2020-03-16 |
Real-time Process |
| S114 |
2020-02-25 |
Real-time Process |
| S113 |
2020-02-18 |
30-day Notice |
| S112 | | |
| S111 |
2019-12-31 |
30-day Notice |
| S110 | | |
| S109 | | |
| S108 |
2019-09-17 |
30-day Notice |
| S107 |
2019-08-30 |
Normal 180 Day Track No User Fee |
| S106 |
2019-08-15 |
Real-time Process |
| S105 |
2019-06-20 |
30-day Notice |
| S104 | | |
| S103 |
2019-04-23 |
30-day Notice |
| S102 |
2019-03-18 |
30-day Notice |
| S101 | | |
| S100 |
2019-01-23 |
30-day Notice |
| S099 | | |
| S098 |
2018-09-12 |
Normal 180 Day Track |
| S097 |
2018-08-22 |
Real-time Process |
| S096 |
2018-07-13 |
Normal 180 Day Track |
| S095 |
2018-07-10 |
30-day Notice |
| S094 |
2018-06-14 |
135 Review Track For 30-day Notice |
| S093 |
2018-05-18 |
30-day Notice |
| S092 |
2018-05-17 |
Real-time Process |
| S091 |
2018-02-23 |
135 Review Track For 30-day Notice |
| S090 |
2018-02-09 |
Normal 180 Day Track |
| S089 |
2018-01-22 |
30-day Notice |
| S088 |
2017-11-20 |
Real-time Process |
| S087 |
2017-10-18 |
Real-time Process |
| S086 |
2017-07-03 |
30-day Notice |
| S085 |
2017-06-06 |
Real-time Process |
| S084 |
2017-05-24 |
Real-time Process |
| S083 |
2017-05-05 |
Real-time Process |
| S082 |
2017-04-20 |
Real-time Process |
| S081 |
2017-02-16 |
Normal 180 Day Track |
| S080 |
2017-01-03 |
30-day Notice |
| S079 |
2016-12-07 |
Normal 180 Day Track |
| S078 | | |
| S077 |
2016-11-21 |
Real-time Process |
| S076 |
2016-08-08 |
Normal 180 Day Track |
| S075 |
2016-07-28 |
Normal 180 Day Track |
| S074 |
2016-06-06 |
Normal 180 Day Track |
| S073 |
2016-05-31 |
30-day Notice |
| S072 |
2016-03-24 |
Real-time Process |
| S071 |
2016-03-03 |
30-day Notice |
| S070 |
2015-12-23 |
Normal 180 Day Track |
| S069 |
2015-12-16 |
Real-time Process |
| S068 |
2015-08-03 |
30-day Notice |
| S067 |
2015-06-09 |
30-day Notice |
| S066 |
2015-05-27 |
30-day Notice |
| S065 |
2015-05-19 |
30-day Notice |
| S064 |
2015-04-29 |
135 Review Track For 30-day Notice |
| S063 |
2015-04-16 |
Normal 180 Day Track |
| S062 |
2015-03-23 |
Normal 180 Day Track |
| S061 |
2015-03-06 |
135 Review Track For 30-day Notice |
| S060 |
2015-02-13 |
Real-time Process |
| S059 |
2015-02-04 |
30-day Notice |
| S058 |
2014-10-31 |
30-day Notice |
| S057 |
2014-09-25 |
Normal 180 Day Track |
| S056 |
2014-09-24 |
30-day Notice |
| S055 |
2014-09-19 |
30-day Notice |
| S054 |
2014-07-28 |
Normal 180 Day Track |
| S053 |
2014-06-23 |
Normal 180 Day Track |
| S052 |
2014-06-23 |
30-day Notice |
| S051 |
2014-05-30 |
30-day Notice |
| S050 |
2013-11-25 |
Normal 180 Day Track |
| S049 |
2013-11-07 |
Real-time Process |
| S048 |
2013-11-05 |
30-day Notice |
| S047 |
2013-08-15 |
Real-time Process |
| S046 |
2013-07-29 |
Real-time Process |
| S045 |
2013-07-16 |
30-day Notice |
| S044 |
2013-06-03 |
Real-time Process |
| S043 |
2013-04-29 |
30-day Notice |
| S042 |
2013-04-22 |
30-day Notice |
| S041 |
2013-04-03 |
Real-time Process |
| S040 | | |
| S039 |
2013-02-05 |
Real-time Process |
| S038 |
2013-01-14 |
30-day Notice |
| S037 |
2012-12-21 |
Real-time Process |
| S036 |
2012-12-18 |
Normal 180 Day Track |
| S035 |
2012-11-19 |
Real-time Process |
| S034 |
2012-09-07 |
30-day Notice |
| S033 |
2012-07-02 |
Real-time Process |
| S032 |
2012-04-02 |
135 Review Track For 30-day Notice |
| S031 |
2012-03-01 |
Normal 180 Day Track |
| S030 |
2012-02-17 |
Real-time Process |
| S029 |
2012-02-06 |
30-day Notice |
| S028 |
2011-11-02 |
Normal 180 Day Track |
| S027 |
2011-10-03 |
Real-time Process |
| S026 |
2011-08-19 |
Normal 180 Day Track |
| S025 |
2011-06-23 |
30-day Notice |
| S024 |
2011-06-16 |
135 Review Track For 30-day Notice |
| S023 |
2011-04-11 |
Real-time Process |
| S022 | | |
| S021 |
2010-12-13 |
Real-time Process |
| S020 |
2010-11-09 |
30-day Notice |
| S019 |
2010-10-28 |
Normal 180 Day Track |
| S018 |
2010-08-20 |
30-day Notice |
| S017 |
2010-06-08 |
Normal 180 Day Track |
| S016 |
2010-05-28 |
Normal 180 Day Track No User Fee |
| S015 |
2010-02-24 |
Normal 180 Day Track |
| S014 |
2009-11-25 |
Real-time Process |
| S013 |
2009-09-30 |
Real-time Process |
| S012 |
2009-09-10 |
Real-time Process |
| S011 |
2009-07-08 |
Normal 180 Day Track |
| S010 |
2009-02-13 |
Real-time Process |
| S009 |
2009-01-26 |
Normal 180 Day Track |
| S008 |
2008-11-17 |
Normal 180 Day Track |
| S007 |
2008-10-31 |
Real-time Process |
| S006 |
2008-09-05 |
30-day Notice |
| S005 |
2008-06-11 |
Normal 180 Day Track No User Fee |
| S004 |
2008-06-04 |
135 Review Track For 30-day Notice |
| S003 |
2008-06-02 |
Real-time Process |
| S002 |
2008-05-15 |
Real-time Process |
| S001 |
2008-05-15 |
Normal 180 Day Track |
NIH GUDID Devices