SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Coronary Drug-eluting Stent

FDA Premarket Approval P150003

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the synergy everolimus-eluting platinum chromium coronary stent system. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stableangina, unstable angina, non-st elevation mi or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >=2. 25 mm to

DeviceSYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Classification NameCoronary Drug-eluting Stent
Generic NameCoronary Drug-eluting Stent
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2015-01-15
Decision Date2015-10-02
Notice Date2015-11-02
PMAP150003
SupplementS
Product CodeNIQ
Docket Number15M-4014
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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

NIH GUDID Devices

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