Approval for firmware modifications for the ingenio and accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated programmer software applications to support the addition of features including signal artifact monitor, automatic lead recognition, mri protection mode, and rightrate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and crt p devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.
| Device | INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC |
| Date Received | 2018-04-30 |
| Decision Date | 2018-07-27 |
| PMA | P150012 |
| Supplement | S060 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BOSTONSCIENTIFIC 4100 Hamline Avenue North st Paul, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150012 | | Original Filing |
| S138 |
2022-12-12 |
30-day Notice |
| S137 |
2022-12-09 |
30-day Notice |
| S136 |
2022-12-07 |
30-day Notice |
| S135 |
2022-11-01 |
30-day Notice |
| S134 | | |
| S133 |
2022-10-05 |
30-day Notice |
| S132 | | |
| S131 | | |
| S130 |
2022-09-20 |
30-day Notice |
| S129 | | |
| S128 |
2022-07-21 |
30-day Notice |
| S127 |
2022-07-21 |
30-day Notice |
| S126 |
2022-06-29 |
30-day Notice |
| S125 | | |
| S124 |
2022-03-28 |
30-day Notice |
| S123 |
2022-02-23 |
30-day Notice |
| S122 |
2021-12-16 |
30-day Notice |
| S121 |
2021-12-07 |
30-day Notice |
| S120 | | |
| S119 |
2021-10-08 |
30-day Notice |
| S118 |
2021-09-30 |
30-day Notice |
| S117 |
2021-09-23 |
30-day Notice |
| S116 | | |
| S115 |
2021-09-01 |
30-day Notice |
| S114 |
2021-06-21 |
Real-time Process |
| S113 |
2021-06-16 |
30-day Notice |
| S112 | | |
| S111 |
2021-04-30 |
30-day Notice |
| S110 |
2021-04-28 |
30-day Notice |
| S109 |
2021-04-26 |
30-day Notice |
| S108 |
2021-03-24 |
30-day Notice |
| S107 |
2021-03-08 |
30-day Notice |
| S106 |
2021-01-11 |
30-day Notice |
| S105 |
2020-12-08 |
30-day Notice |
| S104 | | |
| S103 |
2020-10-21 |
30-day Notice |
| S102 |
2020-10-01 |
30-day Notice |
| S101 |
2020-09-24 |
30-day Notice |
| S100 |
2020-08-13 |
Real-time Process |
| S099 | | |
| S098 |
2020-08-06 |
30-day Notice |
| S097 |
2020-07-27 |
30-day Notice |
| S096 | | |
| S095 |
2020-05-22 |
Normal 180 Day Track No User Fee |
| S094 |
2020-04-30 |
30-day Notice |
| S093 |
2020-04-10 |
30-day Notice |
| S092 | | |
| S091 |
2020-03-13 |
30-day Notice |
| S090 |
2020-03-02 |
30-day Notice |
| S089 |
2020-01-27 |
30-day Notice |
| S088 | | |
| S087 |
2019-12-03 |
30-day Notice |
| S086 |
2019-11-22 |
30-day Notice |
| S085 | | |
| S084 |
2019-10-21 |
30-day Notice |
| S083 | | |
| S082 |
2019-09-10 |
30-day Notice |
| S081 | | |
| S080 |
2019-06-20 |
Real-time Process |
| S079 |
2019-05-31 |
30-day Notice |
| S078 | | |
| S077 |
2019-04-25 |
30-day Notice |
| S076 | | |
| S075 |
2019-03-20 |
Real-time Process |
| S074 |
2019-03-13 |
30-day Notice |
| S073 | | |
| S072 |
2019-02-15 |
30-day Notice |
| S071 |
2019-02-11 |
30-day Notice |
| S070 |
2018-12-26 |
Real-time Process |
| S069 |
2018-12-20 |
30-day Notice |
| S068 | | |
| S067 |
2018-12-03 |
Real-time Process |
| S066 |
2018-10-19 |
30-day Notice |
| S065 |
2018-10-11 |
30-day Notice |
| S064 |
2018-07-13 |
30-day Notice |
| S063 |
2018-06-11 |
30-day Notice |
| S062 |
2018-05-04 |
Real-time Process |
| S061 | | |
| S060 |
2018-04-30 |
Normal 180 Day Track |
| S059 |
2018-04-25 |
30-day Notice |
| S058 |
2018-03-26 |
30-day Notice |
| S057 | | |
| S056 |
2018-03-20 |
30-day Notice |
| S055 |
2018-03-13 |
30-day Notice |
| S054 |
2018-02-16 |
30-day Notice |
| S053 |
2018-01-19 |
30-day Notice |
| S052 |
2018-01-18 |
Real-time Process |
| S051 |
2017-12-14 |
Real-time Process |
| S050 |
2017-11-21 |
30-day Notice |
| S049 |
2017-11-21 |
30-day Notice |
| S048 |
2017-11-20 |
30-day Notice |
| S047 |
2017-11-17 |
30-day Notice |
| S046 |
2017-11-13 |
30-day Notice |
| S045 |
2017-11-02 |
30-day Notice |
| S044 |
2017-10-20 |
Real-time Process |
| S043 |
2017-09-15 |
Real-time Process |
| S042 |
2017-09-29 |
30-day Notice |
| S041 |
2017-09-28 |
30-day Notice |
| S040 |
2017-09-27 |
30-day Notice |
| S039 |
2017-04-03 |
Normal 180 Day Track |
| S038 |
2017-09-05 |
30-day Notice |
| S037 |
2017-09-05 |
30-day Notice |
| S036 |
2017-08-04 |
30-day Notice |
| S035 |
2017-08-02 |
30-day Notice |
| S034 |
2017-07-24 |
Real-time Process |
| S033 |
2017-07-17 |
Real-time Process |
| S032 |
2017-05-26 |
Normal 180 Day Track |
| S031 |
2017-05-01 |
Normal 180 Day Track |
| S030 |
2017-04-26 |
30-day Notice |
| S029 |
2017-04-25 |
30-day Notice |
| S028 |
2017-04-07 |
30-day Notice |
| S027 |
2017-03-30 |
30-day Notice |
| S026 |
2017-03-17 |
30-day Notice |
| S025 |
2016-12-21 |
30-day Notice |
| S024 |
2016-12-19 |
30-day Notice |
| S023 |
2016-12-14 |
30-day Notice |
| S022 |
2016-12-13 |
30-day Notice |
| S021 |
2016-12-09 |
Normal 180 Day Track |
| S020 |
2016-11-18 |
30-day Notice |
| S019 |
2016-11-14 |
30-day Notice |
| S018 |
2016-11-03 |
30-day Notice |
| S017 |
2016-10-03 |
30-day Notice |
| S016 |
2016-09-12 |
30-day Notice |
| S015 |
2016-09-02 |
30-day Notice |
| S014 |
2016-08-17 |
30-day Notice |
| S013 |
2016-07-29 |
Real-time Process |
| S012 |
2016-07-22 |
30-day Notice |
| S011 |
2016-07-07 |
30-day Notice |
| S010 |
2016-07-05 |
30-day Notice |
| S009 |
2016-06-27 |
30-day Notice |
| S008 |
2016-05-27 |
30-day Notice |
| S007 |
2016-05-26 |
30-day Notice |
| S006 |
2016-05-20 |
135 Review Track For 30-day Notice |
| S005 |
2016-05-18 |
30-day Notice |
| S004 |
2016-05-06 |
Real-time Process |
| S003 |
2016-05-04 |
30-day Notice |
| S002 |
2016-05-02 |
30-day Notice |
| S001 |
2016-04-27 |
30-day Notice |
NIH GUDID Devices