Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existingprecautions and the following marketing statements:1) biotronic home monitoring information may be used as a replacement fordevice interrogation during in-office follow-up visits. 2) a strategy of care using biotronik home monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-officefollow-ups of biotronik implantable devices in many patients. Home monitoring data is helpful in determining the need for additional in-office follow-up. 3) biotronik home monitoring patients -who are followed remotely with officevisits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) biotronik home monitoring provides early detection of arrhythmias. 5) biotronik home monitoring provides early detection of silent, asymptomatic arrhythmias. 6) automatic early detection of arrhythmias and device system anomalies bybiotronik home monitoring allows for earlier intervention than conventional in-officefollow-ups. 7) biotronik home monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automaticallyscheduled at regular intervals.
| Device | STRATOS 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 | 2009-01-26 |
| Decision Date | 2009-05-12 |
| PMA | P070008 |
| Supplement | S009 |
| Product Code | NKE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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