Essentio MRI SR/DR SL, Essentio MRI DR EL, Proponent MRI SR/DR SL, Proponent MRI DR EL, Accolade MRI SR/DR SL and Accola

Implantable Pulse Generator, Pacemaker (non-crt)

FDA Premarket Approval P150012 S086

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

To replace the current automated optical inspection equipment system and to update the inspection process

DeviceEssentio MRI SR/DR SL, Essentio MRI DR EL, Proponent MRI SR/DR SL, Proponent MRI DR EL, Accolade MRI SR/DR SL and Accola
Classification NameImplantable Pulse Generator, Pacemaker (non-crt)
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTONSCIENTIFIC
Date Received2019-11-22
Decision Date2019-11-27
PMAP150012
SupplementS086
Product CodeLWP
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTONSCIENTIFIC 4100 Hamline Avenue North st Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P150012Original Filing
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

Device IDPMASupp
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00802526579424 P150012 000
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00802526523304 P150012 000
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00802526523397 P150012 000
00802526523427 P150012 000
00802526523458 P150012 000
00802526523489 P150012 000
00802526558948 P150012 000
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00802526497803 P150012 000
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00802526523335 P150012 000
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00802526523397 P150012 000
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00802526523458 P150012 000
00802526523489 P150012 000
00802526558948 P150012 000
00802526497803 P150012 000

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