PROMUS PREMIER Everolimus-Eluting Chromium Coronary Stent System (Monorail and Over The Wire) and PROMUS ELITE Everolimu

Coronary Drug-eluting Stent

FDA Premarket Approval P110010 S172

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

A change to the annealing process of the corewire component of the delivery system

DevicePROMUS PREMIER Everolimus-Eluting Chromium Coronary Stent System (Monorail and Over The Wire) and PROMUS ELITE Everolimu
Classification NameCoronary Drug-eluting Stent
Generic NameCoronary Drug-eluting Stent
ApplicantBoston Scientific Corp.
Date Received2019-11-01
Decision Date2019-11-26
PMAP110010
SupplementS172
Product CodeNIQ
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P110010Original Filing
S172 2019-11-01 30-day Notice
S171 2019-10-10 30-day Notice
S170 2019-10-01 30-day Notice
S169 2019-09-12 30-day Notice
S168 2019-08-12 30-day Notice
S167 2019-06-27 30-day Notice
S166 2019-06-11 30-day Notice
S165
S164
S163
S162 2019-02-01 30-day Notice
S161 2018-12-21 30-day Notice
S160 2018-10-02 30-day Notice
S159 2018-08-24 30-day Notice
S158 2018-06-13 30-day Notice
S157 2018-05-25 30-day Notice
S156 2018-04-23 30-day Notice
S155 2018-04-06 135 Review Track For 30-day Notice
S154 2018-03-23 Normal 180 Day Track
S153 2018-01-26 30-day Notice
S152 2018-01-17 30-day Notice
S151 2017-11-24 Normal 180 Day Track
S150 2017-11-13 30-day Notice
S149 2017-10-30 30-day Notice
S148 2017-10-18 30-day Notice
S147 2017-10-02 30-day Notice
S146 2017-08-24 30-day Notice
S145 2017-08-18 30-day Notice
S144 2017-08-04 30-day Notice
S143 2017-07-18 30-day Notice
S142 2017-06-26 30-day Notice
S141 2017-04-13 30-day Notice
S140 2017-04-11 30-day Notice
S139 2017-03-13 30-day Notice
S138 2017-03-06 30-day Notice
S137 2016-12-05 Normal 180 Day Track No User Fee
S136 2016-11-22 30-day Notice
S135 2016-11-14 30-day Notice
S134 2016-09-20 30-day Notice
S133 2016-09-07 30-day Notice
S132 2016-08-01 30-day Notice
S131 2016-07-28 30-day Notice
S130 2016-07-25 30-day Notice
S129 2016-07-21 30-day Notice
S128 2016-07-15 30-day Notice
S127 2016-07-15 135 Review Track For 30-day Notice
S126 2016-05-20 30-day Notice
S125 2016-04-22 30-day Notice
S124 2016-04-13 30-day Notice
S123 2016-03-14 Normal 180 Day Track No User Fee
S122 2016-02-24 135 Review Track For 30-day Notice
S121 2016-02-22 30-day Notice
S120 2016-02-18 30-day Notice
S119 2016-01-28 30-day Notice
S118 2016-01-20 Real-time Process
S117 2015-11-16 30-day Notice
S116 2015-09-25 135 Review Track For 30-day Notice
S115 2015-08-07 30-day Notice
S114 2015-07-02 30-day Notice
S113 2015-06-16 30-day Notice
S112 2015-06-09 30-day Notice
S111 2015-06-08 30-day Notice
S110
S109 2015-05-28 30-day Notice
S108 2015-05-19 30-day Notice
S107 2015-05-14 30-day Notice
S106 2015-04-29 30-day Notice
S105 2015-04-07 Real-time Process
S104 2015-03-09 30-day Notice
S103 2015-02-23 30-day Notice
S102 2015-02-19 135 Review Track For 30-day Notice
S101 2014-12-08 Normal 180 Day Track No User Fee
S100 2014-11-21 30-day Notice
S099 2014-10-08 Normal 180 Day Track
S098 2014-10-06 30-day Notice
S097 2014-09-30 30-day Notice
S096 2014-09-30 Panel Track
S095
S094 2014-09-26 30-day Notice
S093 2014-08-26 30-day Notice
S092 2014-08-22 30-day Notice
S091 2014-07-07 30-day Notice
S090 2014-06-19 Real-time Process
S089 2014-06-13 Normal 180 Day Track No User Fee
S088 2014-06-02 30-day Notice
S087 2014-05-05 30-day Notice
S086 2014-05-05 30-day Notice
S085 2014-04-28 135 Review Track For 30-day Notice
S084 2014-04-23 30-day Notice
S083 2014-04-22 Real-time Process
S082 2014-04-15 30-day Notice
S081 2014-04-07 30-day Notice
S080 2014-04-04 30-day Notice
S079 2014-03-31 30-day Notice
S078 2014-03-28 30-day Notice
S077 2014-02-24 30-day Notice
S076 2014-02-12 30-day Notice
S075 2014-02-10 30-day Notice
S074 2014-01-31 30-day Notice
S073 2014-01-31 30-day Notice
S072 2014-01-30 30-day Notice
S071 2014-01-30 30-day Notice
S070 2014-01-29 30-day Notice
S069 2014-01-29 30-day Notice
S068 2014-01-17 30-day Notice
S067 2014-01-15 30-day Notice
S066 2014-01-14 30-day Notice
S065 2014-01-14 30-day Notice
S064 2013-11-26 30-day Notice
S063 2013-11-25 30-day Notice
S062 2013-09-20 30-day Notice
S061 2013-09-19 30-day Notice
S060 2013-08-29 30-day Notice
S059 2013-08-20 30-day Notice
S058 2013-08-16 Normal 180 Day Track
S057 2013-07-22 30-day Notice
S056 2013-07-01 30-day Notice
S055 2013-06-10 30-day Notice
S054
S053 2013-04-25 Normal 180 Day Track
S052
S051 2013-03-29 Real-time Process
S050 2013-02-14 135 Review Track For 30-day Notice
S049
S048 2013-02-04 30-day Notice
S047 2013-01-30 30-day Notice
S046 2013-01-25 30-day Notice
S045 2013-01-18 30-day Notice
S044 2013-01-04 30-day Notice
S043 2012-12-21 30-day Notice
S042 2012-11-27 30-day Notice
S041 2012-11-23 30-day Notice
S040 2012-11-19 30-day Notice
S039 2012-11-16 30-day Notice
S038 2012-11-16 30-day Notice
S037 2012-11-15 30-day Notice
S036 2012-11-09 30-day Notice
S035 2012-11-05 Special (immediate Track)
S034 2012-11-05 30-day Notice
S033 2012-11-02 30-day Notice
S032 2012-10-24 30-day Notice
S031 2012-10-05 30-day Notice
S030 2012-09-26 30-day Notice
S029 2012-09-05 30-day Notice
S028 2012-08-24 Real-time Process
S027 2012-08-13 30-day Notice
S026 2012-07-30 Real-time Process
S025 2012-07-17 30-day Notice
S024 2012-07-16 30-day Notice
S023 2012-06-27 30-day Notice
S022 2012-06-27 30-day Notice
S021 2012-06-26 Normal 180 Day Track No User Fee
S020 2012-06-25 Normal 180 Day Track No User Fee
S019 2012-06-21 30-day Notice
S018 2012-06-20 135 Review Track For 30-day Notice
S017 2012-06-14 30-day Notice
S016 2012-06-13 30-day Notice
S015 2012-06-06 30-day Notice
S014 2012-05-02 30-day Notice
S013
S012 2012-03-26 30-day Notice
S011 2012-03-23 30-day Notice
S010 2012-03-20 135 Review Track For 30-day Notice
S009 2012-03-15 30-day Notice
S008 2012-03-05 30-day Notice
S007 2012-02-14 30-day Notice
S006 2011-12-23
S005 2011-12-23 135 Review Track For 30-day Notice
S004 2011-12-20 Normal 180 Day Track No User Fee
S003 2011-12-16 30-day Notice
S002 2011-12-01 30-day Notice
S001 2011-11-30 Panel Track

NIH GUDID Devices

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