SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

FDA Premarket Approval P150003 S069

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

Approval for integration of automated stent visual inspection process steps

DeviceSYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)
Generic NameCoronary Drug-eluting Stent
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2020-11-20
Decision Date2020-12-08
PMAP150003
SupplementS069
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311

Supplemental Filings

Supplement NumberDateSupplement Type
P150003Original Filing
S089 2022-11-14 30-day Notice
S088
S087 2022-05-06 30-day Notice
S086 2022-05-02 30-day Notice
S085 2022-04-07 30-day Notice
S084 2022-03-14 30-day Notice
S083 2022-01-20 30-day Notice
S082
S081 2021-11-17 30-day Notice
S080 2021-11-16 30-day Notice
S079 2021-09-24 30-day Notice
S078 2021-08-24 30-day Notice
S077 2021-06-22 30-day Notice
S076
S075 2021-05-07 30-day Notice
S074
S073 2021-03-31 30-day Notice
S072 2021-02-26 30-day Notice
S071 2021-02-17 Normal 180 Day Track No User Fee
S070 2021-02-04 30-day Notice
S069 2020-11-20 30-day Notice
S068 2020-11-19 30-day Notice
S067 2020-11-09 30-day Notice
S066
S065 2020-09-29 30-day Notice
S064 2020-08-07 30-day Notice
S063
S062 2020-06-03 30-day Notice
S061 2020-04-24 30-day Notice
S060 2020-03-13 30-day Notice
S059
S058
S057 2019-11-21 30-day Notice
S056 2019-11-06 30-day Notice
S055
S054
S053 2019-08-14 30-day Notice
S052 2019-08-12 30-day Notice
S051 2019-07-12 30-day Notice
S050 2019-06-27 30-day Notice
S049 2019-06-11 30-day Notice
S048 2019-06-04 30-day Notice
S047
S046 2019-02-01 30-day Notice
S045 2018-11-20 30-day Notice
S044 2018-11-14 30-day Notice
S043 2018-11-13 Normal 180 Day Track No User Fee
S042 2018-08-20 30-day Notice
S041 2018-08-01 30-day Notice
S040 2018-06-01 30-day Notice
S039 2018-03-09 Normal 180 Day Track
S038 2018-03-01 30-day Notice
S037 2018-01-26 30-day Notice
S036 2017-11-24 Normal 180 Day Track
S035 2017-11-20 30-day Notice
S034 2017-08-24 30-day Notice
S033 2017-08-18 30-day Notice
S032 2017-07-28 Normal 180 Day Track
S031 2017-05-16 30-day Notice
S030 2017-04-28 30-day Notice
S029 2017-04-11 30-day Notice
S028 2017-03-13 30-day Notice
S027 2016-11-23 30-day Notice
S026 2016-11-22 30-day Notice
S025 2016-11-14 30-day Notice
S024 2016-10-20 30-day Notice
S023 2016-10-17 30-day Notice
S022 2016-09-30 30-day Notice
S021 2016-09-20 30-day Notice
S020 2016-09-07 30-day Notice
S019 2016-08-01 30-day Notice
S018 2016-07-28 30-day Notice
S017 2016-07-25 30-day Notice
S016 2016-07-15 30-day Notice
S015 2016-07-15 135 Review Track For 30-day Notice
S014 2016-05-20 30-day Notice
S013 2016-05-10 Real-time Process
S012 2016-04-22 30-day Notice
S011 2016-04-19 Normal 180 Day Track No User Fee
S010 2016-04-18 30-day Notice
S009 2016-04-13 30-day Notice
S008 2016-03-09 30-day Notice
S007 2016-02-18 30-day Notice
S006 2016-02-17 Normal 180 Day Track
S005 2016-02-04 30-day Notice
S004 2016-01-06 30-day Notice
S003 2015-12-07 Panel Track
S002 2015-12-01 Normal 180 Day Track No User Fee
S001 2015-11-16 30-day Notice

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