This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | ESSENTIO™ MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT™ MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS130 Date Received09/20/2022 Decision Date09/27/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-20 |
| Decision Date | 2022-09-27 |
| PMA | P150012 |
| Supplement | S130 |
| 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 PMA NumberP150012 Supplement NumberS130 Date Received09/20/2022 Decision Date09/27/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement to Implement An Automatic Handling System For The Helium Leak Test Process |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00802526579462 | P150012 | 000 |
| 00802526523489 | P150012 | 000 |
| 00802526523458 | P150012 | 000 |
| 00802526523427 | P150012 | 000 |
| 00802526523397 | P150012 | 000 |
| 00802526523366 | P150012 | 000 |
| 00802526523335 | P150012 | 000 |
| 00802526523304 | P150012 | 000 |
| 00802526497803 | P150012 | 000 |
| 00802526558948 | P150012 | 000 |
| 00802526558962 | P150012 | 000 |
| 00802526559006 | P150012 | 000 |
| 00802526579455 | P150012 | 000 |
| 00802526579448 | P150012 | 000 |
| 00802526579431 | P150012 | 000 |
| 00802526579424 | P150012 | 000 |
| 00802526579417 | P150012 | 000 |
| 00802526559266 | P150012 | 000 |
| 00802526559228 | P150012 | 000 |
| 00802526559204 | P150012 | 000 |
| 00802526604577 | P150012 | 083 |
| 00802526604522 | P150012 | 083 |
| 00802526604430 | P150012 | 083 |