Resolute Integrity Zotarolimus-Eluting Coronary Stent System - RX and OTW

FDA Premarket Approval P110013 S102

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

Addition of alternative equipment for manufacturing of foil pouches.

DeviceResolute Integrity Zotarolimus-Eluting Coronary Stent System - RX and OTW
Generic NameCoronary Drug-eluting Stent
ApplicantMedtronic Vascular
Date Received2020-04-17
Decision Date2020-04-30
PMAP110013
SupplementS102
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P110013Original Filing
S102 2020-04-17 30-day Notice
S101 2020-03-13 30-day Notice
S100 2019-08-29 30-day Notice
S099 2019-08-09 30-day Notice
S098
S097
S096
S095
S094 2019-01-09 Normal 180 Day Track No User Fee
S093 2018-09-24 30-day Notice
S092 2018-09-24 30-day Notice
S091 2018-09-17 Normal 180 Day Track No User Fee
S090 2018-04-02 135 Review Track For 30-day Notice
S089 2018-03-19 30-day Notice
S088 2018-01-16 Panel Track
S087 2017-12-18 Real-time Process
S086 2017-11-22 Normal 180 Day Track No User Fee
S085 2017-11-20 30-day Notice
S084 2017-10-12 30-day Notice
S083 2017-10-10 30-day Notice
S082 2017-09-14 30-day Notice
S081 2017-08-04 30-day Notice
S080 2017-07-03 Real-time Process
S079 2017-05-26 30-day Notice
S078 2016-10-27 30-day Notice
S077 2016-10-11 Real-time Process
S076 2016-09-02 30-day Notice
S075 2016-08-17 135 Review Track For 30-day Notice
S074 2016-07-13 30-day Notice
S073 2016-06-22 30-day Notice
S072 2016-06-06 30-day Notice
S071 2016-05-23 30-day Notice
S070 2016-05-16 30-day Notice
S069 2016-05-12 30-day Notice
S068 2016-04-25 30-day Notice
S067 2016-04-22 135 Review Track For 30-day Notice
S066
S065 2016-04-04 135 Review Track For 30-day Notice
S064 2016-03-15 30-day Notice
S063
S062 2016-03-03 30-day Notice
S061 2016-02-08 30-day Notice
S060 2016-01-29 30-day Notice
S059 2016-01-27 Normal 180 Day Track No User Fee
S058
S057 2015-09-04 30-day Notice
S056 2015-08-21 30-day Notice
S055 2015-08-17 30-day Notice
S054 2015-07-20 30-day Notice
S053 2015-07-20 30-day Notice
S052 2015-05-27 30-day Notice
S051 2015-05-14 30-day Notice
S050 2015-03-20 135 Review Track For 30-day Notice
S049 2014-12-18 Normal 180 Day Track No User Fee
S048 2014-11-17 30-day Notice
S047 2014-11-10 30-day Notice
S046 2014-09-23 Real-time Process
S045 2014-09-12 30-day Notice
S044 2014-08-20 Normal 180 Day Track No User Fee
S043 2014-07-02 30-day Notice
S042 2014-06-25 135 Review Track For 30-day Notice
S041
S040 2014-04-25 30-day Notice
S039 2014-04-03 30-day Notice
S038 2014-03-18 30-day Notice
S037 2014-03-13 30-day Notice
S036 2014-02-18 30-day Notice
S035 2014-02-12 30-day Notice
S034 2014-02-03 Special (immediate Track)
S033 2013-12-23 30-day Notice
S032 2013-12-16 30-day Notice
S031 2013-11-22 30-day Notice
S030 2013-11-18 30-day Notice
S029 2013-11-15 30-day Notice
S028 2013-11-04 Normal 180 Day Track No User Fee
S027 2013-09-26 30-day Notice
S026 2013-09-26 30-day Notice
S025 2013-08-19 30-day Notice
S024 2013-08-09 135 Review Track For 30-day Notice
S023 2013-08-02 30-day Notice
S022 2013-08-01 30-day Notice
S021 2013-08-01 135 Review Track For 30-day Notice
S020 2013-07-18 135 Review Track For 30-day Notice
S019 2013-07-01 30-day Notice
S018 2013-07-01 30-day Notice
S017 2013-04-05 Normal 180 Day Track No User Fee
S016 2013-06-17 Normal 180 Day Track No User Fee
S015 2013-06-10 135 Review Track For 30-day Notice
S014 2013-05-28 30-day Notice
S013 2013-04-30 30-day Notice
S012 2013-04-26 135 Review Track For 30-day Notice
S011 2013-04-10 135 Review Track For 30-day Notice
S010 2013-04-08 30-day Notice
S009 2013-03-14 Special (immediate Track)
S008 2013-03-01 30-day Notice
S007 2013-02-19 Normal 180 Day Track No User Fee
S006
S005 2012-07-09 Panel Track
S004 2012-06-29 30-day Notice
S003 2012-04-27 30-day Notice
S002 2012-05-10 Normal 180 Day Track
S001 2012-03-22 135 Review Track For 30-day Notice

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