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

Coronary Drug-eluting Stent

FDA Premarket Approval P150003 S057

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

Changes to the electrolytic etch process time and number of switches for the synergy sv and lv stent components

DeviceSYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)
Classification NameCoronary Drug-eluting Stent
Generic NameCoronary Drug-eluting Stent
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2019-11-21
Decision Date2019-11-26
PMAP150003
SupplementS057
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
S057 2019-11-21 30-day Notice
S056
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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