Changes to the molding manufacturing line.
| Device | ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC |
| Date Received | 2016-07-07 |
| Decision Date | 2016-08-02 |
| PMA | P150012 |
| Supplement | S011 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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