Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting

FDA Premarket Approval P160043 S062

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

DeviceResolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting
Generic NameCoronary Drug-eluting Stent
ApplicantMEDTRONIC VASCULAR3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP160043 Supplement NumberS062 Date Received10/31/2022 Decision Date11/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-31
Decision Date2022-11-01
PMAP160043
SupplementS062
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMEDTRONIC VASCULAR
3576 Unocal Place
santa Rosa, CA 95403 PMA NumberP160043 Supplement NumberS062 Date Received10/31/2022 Decision Date11/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
the Automation Of A Verification Step Undertaken By Sterile Release Personnel (SRP) For Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing (BET) Prior To Final Release Of Product

Supplemental Filings

Supplement NumberDateSupplement Type
P160043Original Filing
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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