XIENCE Sierra Stent System

FDA Premarket Approval P110019 S112

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 extending the shelf-life for the xience sierra everolimus-eluting coronary stent system from 18 to 24 months and to revise the annual stability testing protocol to align with the other xience stent family members.

DeviceXIENCE Sierra Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantABBOTT VASCULAR
Date Received2020-07-24
Decision Date2020-10-22
PMAP110019
SupplementS112
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P110019Original Filing
S112 2020-07-24 Real-time Process
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.