SICD Gen 2 and SICD MRI

FDA Premarket Approval P110042 S135

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.

Pre-market Approval Supplement Details

Implement the cms system for the monitoring of environmental conditions at the boston scientific clonmel facility.

DeviceSICD Gen 2 and SICD MRI
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2020-03-13
Decision Date2020-03-17
PMAP110042
SupplementS135
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC CORPORATION 4100 Hamline Avenue North st. Paul, MN 55112-5798

Supplemental Filings

Supplement NumberDateSupplement Type
P110042Original Filing
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

Device IDPMASupp
00802526521300 P110042 000
00802526531019 P110042 000
00802526531033 P110042 000
00802526553707 P110042 000
00802526521300 P110042 000
00802526524806 P110042 000
00802526553707 P110042 000
00802526531033 P110042 000
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00802526524806 P110042 000
00802526542220 P110042 009
00802526542206 P110042 009
00802526542206 P110042 009
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00802526542244 P110042 009
00802526562808 P110042 017
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00802526563201 P110042 017
00802526562808 P110042 017
00802526569401 P110042 033
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00802526573507 P110042 043
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00802526586507 P110042 058
00802526586507 P110042 058
00802526585982 P110042 058
00802526585968 P110042 058
00802526584404 P110042 058
00802526605345 P110042 058
00802526605345 P110042 058
00802526599200 P110042 077
00802526599200 P110042 077
00802526591907 P110042 102
00802526591907 P110042 102
00802526609206 P110042 123
00802526610516 P110042 123

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