Approval for the addition of 3t mr conditional labeling for the image ready mr conditional pacing system consisting of an accolade mri pacemaker with one or two ingevity mri leads. Approval to expand the image ready system to include 1. 5t mr conditional labeling for the fineline ii sterox and sterox ez leads.
| Device | ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS) |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC |
| Date Received | 2016-12-09 |
| Decision Date | 2017-04-11 |
| PMA | P150012 |
| Supplement | S021 |
| 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