Addition of new molding preparation equipment with updated software, application of existing overmolding equipment already in use for other leads, and duplication of existing process monitoring testing to monitor output of the added equipment.
| Device | INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC |
| Date Received | 2018-06-11 |
| Decision Date | 2018-07-05 |
| PMA | P150012 |
| Supplement | S063 |
| 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