Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems

Coronary Drug-eluting Stent

FDA Premarket Approval P160043 S007

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 a material change to the distal inner shaft of the resolute onyx zotarolimus-eluting coronary stent systems (rx & otw).

DeviceResolute Onyx Zotarolimus-Eluting Coronary Stent Systems
Classification NameCoronary Drug-eluting Stent
Generic NameCoronary Drug-eluting Stent
ApplicantMEDTRONIC VASCULAR
Date Received2017-09-25
Decision Date2017-12-06
PMAP160043
SupplementS007
Product CodeNIQ
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC VASCULAR 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P160043Original Filing
S064 2022-11-29 30-day Notice
S063 2022-11-18 30-day Notice
S062 2022-10-31 30-day Notice
S061 2022-06-03 30-day Notice
S060
S059 2022-03-23 30-day Notice
S058
S057 2021-12-16 Special (immediate Track)
S056 2021-10-25 30-day Notice
S055
S054 2021-08-02 30-day Notice
S053
S052 2021-07-16 30-day Notice
S051 2021-07-15 30-day Notice
S050 2021-06-30 30-day Notice
S049
S048
S047 2021-04-23 Special (immediate Track)
S046 2021-04-12 30-day Notice
S045
S044 2021-03-04 30-day Notice
S043 2021-01-25 30-day Notice
S042 2021-01-19 30-day Notice
S041
S040 2020-12-07 30-day Notice
S039
S038 2020-08-27 30-day Notice
S037
S036
S035 2020-04-17 30-day Notice
S034
S033 2020-03-13 30-day Notice
S032
S031 2020-02-25 Real-time Process
S030
S029 2019-11-18 30-day Notice
S028 2019-08-29 30-day Notice
S027
S026 2019-08-09 30-day Notice
S025
S024
S023 2019-03-28 30-day Notice
S022 2019-02-25 30-day Notice
S021 2019-01-09 Normal 180 Day Track No User Fee
S020 2018-09-24 30-day Notice
S019 2018-09-24 30-day Notice
S018 2018-09-13 135 Review Track For 30-day Notice
S017 2018-09-04 30-day Notice
S016 2018-04-02 135 Review Track For 30-day Notice
S015 2018-03-19 30-day Notice
S014 2018-03-19 30-day Notice
S013 2018-02-13 Normal 180 Day Track
S012 2018-01-16 Panel Track
S011 2017-12-18 Real-time Process
S010 2017-10-12 30-day Notice
S009 2017-10-10 30-day Notice
S008 2017-10-05 30-day Notice
S007 2017-09-25 Real-time Process
S006 2017-08-16 30-day Notice
S005 2017-08-04 30-day Notice
S004 2017-07-10 30-day Notice
S003 2017-06-19 30-day Notice
S002 2017-05-26 30-day Notice
S001 2017-05-23 Panel Track

NIH GUDID Devices

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