XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE

FDA Premarket Approval P110019 S111

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

To extend the retest period from 96 months to 108 months of the repackaged drug api (variants 1, 2, and 3) for container closure configuration i

DeviceXIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE
Generic NameCoronary Drug-eluting Stent
ApplicantABBOTT VASCULAR
Date Received2020-02-13
Decision Date2020-03-12
PMAP110019
SupplementS111
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P110019Original Filing
S111 2020-02-13 30-day Notice
S110 2020-01-13 30-day Notice
S109
S108
S107 2019-08-12 30-day Notice
S106
S105 2019-06-12 30-day Notice
S104 2019-01-24 30-day Notice
S103 2018-10-24 30-day Notice
S102 2018-09-05 30-day Notice
S101 2018-08-03 30-day Notice
S100 2018-03-23 30-day Notice
S099 2018-03-05 Normal 180 Day Track No User Fee
S098 2018-03-01 Normal 180 Day Track
S097 2018-01-26 30-day Notice
S096 2017-12-11 Normal 180 Day Track No User Fee
S095 2017-09-28 135 Review Track For 30-day Notice
S094 2017-09-01 Normal 180 Day Track
S093 2017-05-17 30-day Notice
S092 2017-04-05 30-day Notice
S091
S090 2017-03-03 30-day Notice
S089 2016-12-06 Normal 180 Day Track
S088 2016-11-23 30-day Notice
S087 2016-09-12 135 Review Track For 30-day Notice
S086 2016-09-06 30-day Notice
S085 2016-07-08 Normal 180 Day Track No User Fee
S084 2016-03-16 30-day Notice
S083 2016-03-16 30-day Notice
S082 2016-03-01 30-day Notice
S081 2016-02-16 30-day Notice
S080 2015-11-16 135 Review Track For 30-day Notice
S079 2015-09-25 30-day Notice
S078 2015-09-24 30-day Notice
S077
S076
S075 2015-02-02 Panel Track
S074 2015-01-14 30-day Notice
S073 2014-09-26 30-day Notice
S072 2014-09-25 30-day Notice
S071 2014-08-27 30-day Notice
S070 2014-06-04 Real-time Process
S069 2014-04-30 135 Review Track For 30-day Notice
S068 2014-04-21 Real-time Process
S067 2014-04-14 30-day Notice
S066 2014-03-21 Panel Track
S065 2014-03-18 30-day Notice
S064 2014-02-10 30-day Notice
S063 2014-01-31 135 Review Track For 30-day Notice
S062 2014-01-30 Normal 180 Day Track No User Fee
S061 2014-01-13 Real-time Process
S060 2013-12-23 135 Review Track For 30-day Notice
S059 2013-12-12 30-day Notice
S058 2013-12-09 Normal 180 Day Track No User Fee
S057 2013-10-24 30-day Notice
S056 2013-10-18 30-day Notice
S055 2013-10-18 Real-time Process
S054 2013-09-30 30-day Notice
S053 2013-08-30 Normal 180 Day Track No User Fee
S052 2013-08-14 30-day Notice
S051 2013-07-29 30-day Notice
S050 2013-06-28 Normal 180 Day Track
S049 2013-05-31 30-day Notice
S048 2013-06-28 Real-time Process
S047 2013-05-22 Real-time Process
S046 2013-05-14 30-day Notice
S045 2013-05-08 Normal 180 Day Track No User Fee
S044 2013-04-22 30-day Notice
S043 2013-04-17 Real-time Process
S042 2013-02-19 30-day Notice
S041 2013-01-22 Normal 180 Day Track No User Fee
S040 2013-01-22 30-day Notice
S039 2013-01-17 Normal 180 Day Track No User Fee
S038
S037 2012-11-09 30-day Notice
S036
S035 2012-10-02 30-day Notice
S034 2012-09-28 30-day Notice
S033 2012-09-11 30-day Notice
S032
S031 2012-08-27 Normal 180 Day Track
S030 2012-08-13 30-day Notice
S029
S028 2012-07-30 30-day Notice
S027 2012-07-25 30-day Notice
S026 2012-07-20 30-day Notice
S025 2012-06-27 Normal 180 Day Track
S024 2012-06-11 30-day Notice
S023 2012-06-07 Normal 180 Day Track No User Fee
S022
S021 2012-05-22 30-day Notice
S020 2012-06-19 Normal 180 Day Track
S019 2012-05-11 30-day Notice
S018 2012-05-29 Normal 180 Day Track
S017 2012-03-27 30-day Notice
S016 2012-03-13 30-day Notice
S015 2012-02-23 30-day Notice
S014 2012-02-22 Normal 180 Day Track No User Fee
S013 2012-02-06 30-day Notice
S012 2012-02-03 30-day Notice
S011 2012-02-01 135 Review Track For 30-day Notice
S010 2012-01-31 30-day Notice
S009 2012-01-24 Normal 180 Day Track No User Fee
S008 2011-12-21 30-day Notice
S007 2011-12-21 30-day Notice
S006 2011-12-19 30-day Notice
S005 2011-12-01 30-day Notice
S004 2011-11-18 30-day Notice
S003
S002 2011-11-14 Real-time Process
S001 2011-11-02 Normal 180 Day Track No User Fee

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