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 | PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS126 Date Received06/29/2022 Decision Date07/13/2022 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 | 2022-06-29 |
| Decision Date | 2022-07-13 |
| PMA | P150012 |
| Supplement | S126 |
| 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 NumberS126 Date Received06/29/2022 Decision Date07/13/2022 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 the Addition Of Ansell Nitrile Gloves As An Alternative Glove For Use During Cardiac Rhythm Management (CRM) Pulse Generator Manufacturing At The St. Paul Site |
| 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 |