XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Coronary Drug-eluting Stent

FDA Premarket Approval P070015 S122

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 the expansion of the indications for use of the xience v and xience nano everolimus eluting coronary stent system xience prime and xience prime ll everolimus eluting coronary stent system, xience xpedition, xience xpedition sv and xience xpedition ll everolimus eluting coronary stent system, and xience alpine everolimus eluting coronary stent system to include de novo total coronary occlusions.. These devices are indicated for the following:xience v and xience nano everolimus eluting coronary stent systemthe xience v and xience nano everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length =4. 25mm. For additional info please refer to approval order.

DeviceXIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification NameCoronary Drug-eluting Stent
Generic NameCoronary Drug-eluting Stent
ApplicantABBOTT VASCULAR INC.
Date Received2014-03-21
Decision Date2014-10-03
Notice Date2014-10-29
PMAP070015
SupplementS122
Product CodeNIQ
Docket Number14M-1596
Advisory CommitteeCardiovascular
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT VASCULAR INC. 26531 Ynez Road, Building G p.o.box 9018 temecula, CA 92589-9018
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P070015Original Filing
S148 2021-02-22 30-day Notice
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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