New controlled environment area (cea) level viii for battery testing.
Device | EMBLEM S-ICD; EMBLEM MRI S-ICD |
Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
Applicant | BOSTON SCIENTIFIC CORPORATION |
Date Received | 2018-01-19 |
Decision Date | 2018-02-08 |
PMA | P110042 |
Supplement | S103 |
Product Code | LWS |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | BOSTON SCIENTIFIC CORPORATION 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P110042 | | Original Filing |
S177 |
2022-12-07 |
30-day Notice |
S176 |
2022-11-10 |
30-day Notice |
S175 |
2022-10-05 |
30-day Notice |
S174 | | |
S173 | | |
S172 |
2022-09-20 |
30-day Notice |
S171 |
2022-06-29 |
30-day Notice |
S170 |
2022-06-16 |
30-day Notice |
S169 |
2022-04-25 |
Normal 180 Day Track No User Fee |
S168 |
2021-12-16 |
30-day Notice |
S167 | | |
S166 | | |
S165 |
2021-10-08 |
30-day Notice |
S164 | | |
S163 |
2021-09-30 |
30-day Notice |
S162 |
2021-09-23 |
30-day Notice |
S161 | | |
S160 | | |
S159 | | |
S158 |
2021-09-01 |
30-day Notice |
S157 |
2021-06-21 |
Real-time Process |
S156 |
2021-04-26 |
30-day Notice |
S155 |
2021-03-29 |
30-day Notice |
S154 | | |
S153 |
2021-03-08 |
30-day Notice |
S152 |
2021-01-11 |
30-day Notice |
S151 |
2020-12-10 |
30-day Notice |
S150 | | |
S149 |
2020-11-03 |
30-day Notice |
S148 | | |
S147 | | |
S146 |
2020-09-24 |
30-day Notice |
S145 |
2020-08-25 |
30-day Notice |
S144 | | |
S143 | | |
S142 | | |
S141 |
2020-07-27 |
30-day Notice |
S140 |
2020-07-08 |
30-day Notice |
S139 |
2020-06-24 |
30-day Notice |
S138 |
2020-05-27 |
30-day Notice |
S137 | | |
S136 |
2020-04-06 |
30-day Notice |
S135 |
2020-03-13 |
30-day Notice |
S134 |
2020-03-02 |
30-day Notice |
S133 | | |
S132 |
2019-12-23 |
Normal 180 Day Track |
S131 |
2019-11-22 |
30-day Notice |
S130 |
2019-10-21 |
30-day Notice |
S129 | | |
S128 |
2019-09-18 |
30-day Notice |
S127 |
2019-08-30 |
30-day Notice |
S126 |
2019-06-14 |
30-day Notice |
S125 |
2019-03-20 |
Real-time Process |
S124 |
2019-03-13 |
30-day Notice |
S123 |
2019-03-04 |
Real-time Process |
S122 |
2019-03-01 |
30-day Notice |
S121 |
2018-12-26 |
30-day Notice |
S120 |
2018-12-26 |
Real-time Process |
S119 |
2018-12-03 |
Real-time Process |
S118 |
2018-11-27 |
30-day Notice |
S117 |
2018-11-08 |
30-day Notice |
S116 |
2018-10-19 |
30-day Notice |
S115 |
2018-10-05 |
30-day Notice |
S114 |
2018-09-26 |
30-day Notice |
S113 |
2018-09-04 |
30-day Notice |
S112 |
2018-08-30 |
30-day Notice |
S111 |
2018-07-13 |
30-day Notice |
S110 |
2018-05-22 |
30-day Notice |
S109 |
2018-05-07 |
30-day Notice |
S108 |
2018-05-02 |
30-day Notice |
S107 |
2018-04-17 |
30-day Notice |
S106 |
2018-03-26 |
30-day Notice |
S105 |
2018-03-05 |
30-day Notice |
S104 |
2018-02-16 |
30-day Notice |
S103 |
2018-01-19 |
30-day Notice |
S102 |
2017-12-19 |
Normal 180 Day Track |
S101 |
2017-12-19 |
30-day Notice |
S100 |
2017-12-18 |
30-day Notice |
S099 |
2017-12-18 |
30-day Notice |
S098 |
2017-11-21 |
30-day Notice |
S097 |
2017-11-20 |
30-day Notice |
S096 |
2017-11-02 |
30-day Notice |
S095 |
2017-10-30 |
30-day Notice |
S094 |
2017-09-28 |
30-day Notice |
S093 |
2017-09-20 |
30-day Notice |
S092 |
2017-09-15 |
Real-time Process |
S091 |
2017-08-04 |
30-day Notice |
S090 |
2017-07-24 |
30-day Notice |
S089 |
2017-07-18 |
Real-time Process |
S088 |
2017-07-17 |
Real-time Process |
S087 |
2017-06-07 |
Real-time Process |
S086 |
2017-05-22 |
Real-time Process |
S085 |
2017-05-10 |
30-day Notice |
S084 |
2017-04-28 |
30-day Notice |
S083 |
2017-04-03 |
Normal 180 Day Track |
S082 |
2017-03-29 |
30-day Notice |
S081 |
2017-03-27 |
30-day Notice |
S080 |
2017-03-27 |
Real-time Process |
S079 |
2017-02-22 |
30-day Notice |
S078 |
2017-02-07 |
30-day Notice |
S077 |
2017-02-06 |
Normal 180 Day Track |
S076 |
2017-02-03 |
30-day Notice |
S075 |
2017-01-23 |
30-day Notice |
S074 |
2016-12-20 |
30-day Notice |
S073 |
2016-12-19 |
30-day Notice |
S072 |
2016-12-14 |
30-day Notice |
S071 |
2016-11-22 |
30-day Notice |
S070 |
2016-11-22 |
Real-time Process |
S069 |
2016-10-31 |
30-day Notice |
S068 |
2016-10-26 |
Normal 180 Day Track |
S067 |
2016-10-19 |
Normal 180 Day Track |
S066 |
2016-10-03 |
30-day Notice |
S065 |
2016-09-16 |
30-day Notice |
S064 |
2016-09-12 |
30-day Notice |
S063 |
2016-09-02 |
30-day Notice |
S062 |
2016-08-17 |
30-day Notice |
S061 |
2016-07-07 |
30-day Notice |
S060 |
2016-07-01 |
Real-time Process |
S059 |
2016-04-21 |
Real-time Process |
S058 |
2016-02-12 |
Normal 180 Day Track |
S057 |
2015-12-21 |
Real-time Process |
S056 |
2015-11-13 |
30-day Notice |
S055 |
2015-11-04 |
30-day Notice |
S054 | | |
S053 |
2015-10-14 |
30-day Notice |
S052 |
2015-09-30 |
30-day Notice |
S051 |
2015-09-23 |
30-day Notice |
S050 |
2015-09-17 |
30-day Notice |
S049 |
2015-07-29 |
30-day Notice |
S048 | | |
S047 | | |
S046 | | |
S045 |
2015-04-27 |
Real-time Process |
S044 | | |
S043 |
2014-11-14 |
Normal 180 Day Track |
S042 |
2014-11-03 |
30-day Notice |
S041 |
2014-09-29 |
30-day Notice |
S040 |
2014-08-11 |
30-day Notice |
S039 |
2014-06-16 |
Special (immediate Track) |
S038 |
2014-06-12 |
Normal 180 Day Track No User Fee |
S037 |
2014-06-02 |
30-day Notice |
S036 | | |
S035 |
2014-05-08 |
30-day Notice |
S034 |
2014-05-08 |
30-day Notice |
S033 |
2014-05-05 |
30-day Notice |
S032 |
2014-04-14 |
30-day Notice |
S031 |
2014-04-09 |
30-day Notice |
S030 | | |
S029 |
2014-03-18 |
Normal 180 Day Track |
S028 |
2014-03-18 |
30-day Notice |
S027 |
2014-02-21 |
30-day Notice |
S026 |
2014-01-14 |
30-day Notice |
S025 |
2014-01-10 |
30-day Notice |
S024 |
2013-12-23 |
30-day Notice |
S023 |
2013-11-20 |
30-day Notice |
S022 |
2013-11-13 |
30-day Notice |
S021 |
2013-11-06 |
30-day Notice |
S020 |
2013-11-06 |
Normal 180 Day Track |
S019 |
2013-10-30 |
30-day Notice |
S018 |
2013-10-23 |
30-day Notice |
S017 |
2013-09-03 |
Normal 180 Day Track No User Fee |
S016 |
2013-09-03 |
Real-time Process |
S015 |
2013-08-30 |
30-day Notice |
S014 |
2013-08-05 |
Real-time Process |
S013 |
2013-08-01 |
30-day Notice |
S012 |
2013-07-02 |
Real-time Process |
S011 |
2013-06-21 |
Real-time Process |
S010 |
2013-06-14 |
30-day Notice |
S009 |
2013-06-10 |
Normal 180 Day Track |
S008 |
2013-04-22 |
30-day Notice |
S007 |
2013-04-04 |
Real-time Process |
S006 |
2013-03-18 |
30-day Notice |
S005 |
2013-02-28 |
Real-time Process |
S004 |
2013-01-11 |
Real-time Process |
S003 |
2012-12-13 |
Real-time Process |
S002 |
2012-12-10 |
Normal 180 Day Track |
S001 |
2012-11-13 |
30-day Notice |
NIH GUDID Devices