XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System

FDA Premarket Approval P070015 S147

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 V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantABBOTT VASCULAR INC.
Date Received2020-02-13
Decision Date2020-03-12
PMAP070015
SupplementS147
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT VASCULAR INC. 26531 Ynez Road, Building G p.o.box 9018 temecula, CA 92589-9018

Supplemental Filings

Supplement NumberDateSupplement Type
P070015Original Filing
S147 2020-02-13 30-day Notice
S146 2019-09-26 135 Review Track For 30-day Notice
S145 2019-06-12 30-day Notice
S144 2019-01-24 30-day Notice
S143 2018-09-05 30-day Notice
S142 2018-03-23 30-day Notice
S141 2018-03-01 Normal 180 Day Track
S140 2018-01-26 30-day Notice
S139 2017-12-11 Normal 180 Day Track No User Fee
S138 2017-09-28 135 Review Track For 30-day Notice
S137 2017-05-17 30-day Notice
S136 2017-04-05 30-day Notice
S135 2016-11-23 30-day Notice
S134 2016-09-12 135 Review Track For 30-day Notice
S133 2016-07-08 Normal 180 Day Track No User Fee
S132 2015-11-16 135 Review Track For 30-day Notice
S131 2015-09-25 30-day Notice
S130
S129
S128 2015-02-02 Panel Track
S127 2015-01-14 30-day Notice
S126 2014-09-26 30-day Notice
S125 2014-09-25 30-day Notice
S124 2014-08-27 30-day Notice
S123 2014-04-14 30-day Notice
S122 2014-03-21 Panel Track
S121 2014-03-18 30-day Notice
S120 2014-02-10 30-day Notice
S119 2013-12-23 135 Review Track For 30-day Notice
S118 2013-12-12 30-day Notice
S117 2013-11-27 Normal 180 Day Track No User Fee
S116 2013-10-24 30-day Notice
S115 2013-10-18 30-day Notice
S114 2013-09-30 30-day Notice
S113 2013-07-29 30-day Notice
S112 2013-05-31 30-day Notice
S111 2013-05-17 135 Review Track For 30-day Notice
S110 2013-05-14 30-day Notice
S109 2013-04-30 Normal 180 Day Track No User Fee
S108 2013-04-08 Normal 180 Day Track No User Fee
S107 2013-04-02 Normal 180 Day Track
S106 2013-01-22 30-day Notice
S105
S104 2012-11-09 30-day Notice
S103
S102 2012-10-02 30-day Notice
S101 2012-09-28 30-day Notice
S100
S099 2012-08-13 30-day Notice
S098 2012-07-30 30-day Notice
S097 2012-07-20 30-day Notice
S096 2012-06-11 30-day Notice
S095
S094 2012-06-19 Normal 180 Day Track
S093 2012-05-14 135 Review Track For 30-day Notice
S092 2012-03-12 Normal 180 Day Track No User Fee
S091 2012-02-23 30-day Notice
S090 2012-02-06 30-day Notice
S089 2012-02-03 30-day Notice
S088 2012-02-01 135 Review Track For 30-day Notice
S087 2012-01-24 Normal 180 Day Track No User Fee
S086 2012-01-09 135 Review Track For 30-day Notice
S085 2011-12-21 30-day Notice
S084
S083 2011-10-24 30-day Notice
S082 2011-10-19 Normal 180 Day Track
S081 2011-10-11 30-day Notice
S080 2011-08-30 30-day Notice
S079 2011-08-02 30-day Notice
S078 2011-07-26 30-day Notice
S077 2011-07-22 Normal 180 Day Track
S076 2011-07-18 30-day Notice
S075 2011-06-09 135 Review Track For 30-day Notice
S074 2011-06-01 30-day Notice
S073
S072 2011-05-09 135 Review Track For 30-day Notice
S071 2011-05-02 135 Review Track For 30-day Notice
S070 2011-04-18 Normal 180 Day Track No User Fee
S069 2011-04-13 30-day Notice
S068 2011-04-11 30-day Notice
S067 2011-04-04 30-day Notice
S066 2011-03-30 30-day Notice
S065 2011-03-29 30-day Notice
S064 2011-03-28 135 Review Track For 30-day Notice
S063 2011-03-28 30-day Notice
S062 2011-03-21 30-day Notice
S061 2011-03-18 30-day Notice
S060 2011-02-11 135 Review Track For 30-day Notice
S059 2011-03-04 30-day Notice
S058 2011-02-11 135 Review Track For 30-day Notice
S057
S056 2011-02-01 30-day Notice
S055 2010-12-02 30-day Notice
S054 2010-11-26 Panel Track
S053 2010-11-15 30-day Notice
S052 2010-11-01 30-day Notice
S051 2010-10-13 30-day Notice
S050 2010-10-12 30-day Notice
S049
S048 2010-09-14 30-day Notice
S047 2010-09-07 30-day Notice
S046 2010-09-03 135 Review Track For 30-day Notice
S045 2010-09-02 135 Review Track For 30-day Notice
S044 2010-08-05 30-day Notice
S043 2010-07-27 30-day Notice
S042 2010-07-23 30-day Notice
S041 2010-07-22 30-day Notice
S040 2010-06-23 30-day Notice
S039 2010-06-22 30-day Notice
S038 2010-06-18 135 Review Track For 30-day Notice
S037 2010-05-13 30-day Notice
S036 2010-04-29 Normal 180 Day Track
S035 2010-04-23 30-day Notice
S034 2010-04-20 30-day Notice
S033 2010-03-23 30-day Notice
S032 2010-02-01 30-day Notice
S031 2010-01-19 135 Review Track For 30-day Notice
S030
S029 2009-11-24 30-day Notice
S028 2009-11-12 Real-time Process
S027 2009-10-21 30-day Notice
S026 2009-09-22 30-day Notice
S025 2009-09-21 30-day Notice
S024 2009-09-15 30-day Notice
S023 2009-07-29 30-day Notice
S022 2009-07-21 135 Review Track For 30-day Notice
S021 2009-06-24 30-day Notice
S020 2009-06-03 30-day Notice
S019 2009-06-02 30-day Notice
S018 2009-05-19 30-day Notice
S017 2009-05-01 135 Review Track For 30-day Notice
S016 2009-04-30 30-day Notice
S015 2009-04-13 30-day Notice
S014 2009-03-02 135 Review Track For 30-day Notice
S013 2009-02-26 30-day Notice
S012 2009-02-02 30-day Notice
S011 2009-01-21 30-day Notice
S010 2009-01-14 Real-time Process
S009
S008 2008-11-17 30-day Notice
S007 2008-11-05 30-day Notice
S006 2008-09-15 30-day Notice
S005 2008-08-21 30-day Notice
S004 2008-08-08 30-day Notice
S003 2008-07-29 30-day Notice
S002 2008-07-18 Normal 180 Day Track
S001 2008-07-16 Normal 180 Day Track

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