Allure, Allure Quadra, and Quadra Allure MP

FDA Premarket Approval P030035 S180

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

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DeviceAllure, Allure Quadra, and Quadra Allure MP
Generic NamePulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
ApplicantSt. Jude Medical, Inc.
Date Received2020-02-13
Decision Date2020-02-28
PMAP030035
SupplementS180
Product CodeNKE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342

Supplemental Filings

Supplement NumberDateSupplement Type
P030035Original Filing
S180 2020-02-13 30-day Notice
S179 2019-12-09 30-day Notice
S178
S177 2019-10-30 Real-time Process
S176 2018-11-20 30-day Notice
S175 2018-10-29 Real-time Process
S174 2018-09-28 30-day Notice
S173 2018-09-04 30-day Notice
S172 2018-07-17 30-day Notice
S171 2018-06-28 Normal 180 Day Track
S170 2018-05-21 30-day Notice
S169 2018-04-10 30-day Notice
S168 2018-04-05 30-day Notice
S167 2018-02-07 30-day Notice
S166 2018-01-31 30-day Notice
S165 2018-01-29 30-day Notice
S164 2018-01-18 Normal 180 Day Track
S163 2017-12-07 30-day Notice
S162 2017-10-30 Real-time Process
S161 2017-10-10 30-day Notice
S160 2017-09-21 30-day Notice
S159 2017-08-16 30-day Notice
S158 2017-07-31 Real-time Process
S157 2017-05-17 Normal 180 Day Track
S156 2017-04-06 30-day Notice
S155 2017-02-28 30-day Notice
S154 2017-02-07 Real-time Process
S153 2017-02-01 Real-time Process
S152 2017-01-30 30-day Notice
S151 2016-12-14 Real-time Process
S150 2016-10-21 30-day Notice
S149 2016-08-30 30-day Notice
S148 2016-07-25 30-day Notice
S147 2016-04-26 Real-time Process
S146 2016-04-04 Real-time Process
S145
S144 2015-12-07 30-day Notice
S143 2015-11-25 30-day Notice
S142 2015-11-12 30-day Notice
S141 2015-10-26 135 Review Track For 30-day Notice
S140 2015-09-29 Real-time Process
S139 2015-09-15 Normal 180 Day Track
S138 2015-08-17 Normal 180 Day Track
S137 2015-08-10 30-day Notice
S136 2015-07-23 Real-time Process
S135 2015-05-19 Real-time Process
S134 2015-04-15 30-day Notice
S133 2015-02-11 Normal 180 Day Track
S132 2015-02-04 Real-time Process
S131 2014-12-18 Real-time Process
S130
S129 2014-11-03 Real-time Process
S128 2014-10-27 30-day Notice
S127 2014-10-20 Real-time Process
S126 2014-10-06 Real-time Process
S125 2014-09-15 Real-time Process
S124 2014-08-07 30-day Notice
S123 2014-07-02 Normal 180 Day Track
S122 2014-06-12 30-day Notice
S121 2014-05-28 30-day Notice
S120 2014-04-15 Real-time Process
S119 2014-04-08 30-day Notice
S118 2014-03-25 30-day Notice
S117 2014-02-05 30-day Notice
S116 2014-01-24 Real-time Process
S115 2013-11-21 Normal 180 Day Track
S114 2013-11-05 30-day Notice
S113 2013-09-05 30-day Notice
S112 2013-08-06 30-day Notice
S111 2013-05-02 30-day Notice
S110 2013-04-15 30-day Notice
S109 2012-12-11 135 Review Track For 30-day Notice
S108 2012-12-05 Normal 180 Day Track
S107 2012-11-14 Normal 180 Day Track
S106
S105 2012-09-28 30-day Notice
S104 2012-09-13 30-day Notice
S103 2012-08-27 30-day Notice
S102 2012-08-16 30-day Notice
S101 2012-08-16 Real-time Process
S100 2012-08-15 30-day Notice
S099 2012-07-11 Real-time Process
S098 2012-07-11 Normal 180 Day Track
S097 2012-05-30 Real-time Process
S096 2012-04-03 30-day Notice
S095 2012-02-29 Real-time Process
S094 2012-02-22 Real-time Process
S093 2012-01-10 30-day Notice
S092
S091 2011-12-05 30-day Notice
S090 2011-11-30 135 Review Track For 30-day Notice
S089 2011-11-01 Normal 180 Day Track
S088 2011-08-31 Real-time Process
S087 2011-08-08 Real-time Process
S086 2011-06-28 Real-time Process
S085 2011-06-08 Real-time Process
S084 2011-05-18 Normal 180 Day Track No User Fee
S083 2011-05-02 Normal 180 Day Track
S082 2011-04-19 Normal 180 Day Track
S081 2011-04-05 30-day Notice
S080
S079 2011-03-22 135 Review Track For 30-day Notice
S078 2011-03-09 135 Review Track For 30-day Notice
S077 2011-01-24 30-day Notice
S076 2010-12-16 30-day Notice
S075 2010-11-23 Normal 180 Day Track
S074 2010-10-12 30-day Notice
S073 2010-08-16 Normal 180 Day Track No User Fee
S072 2010-07-30 Real-time Process
S071 2010-06-17 30-day Notice
S070 2010-06-07 Normal 180 Day Track
S069 2010-05-21 30-day Notice
S068 2010-05-21 30-day Notice
S067 2010-03-26 30-day Notice
S066 2010-02-04 30-day Notice
S065 2009-12-24 30-day Notice
S064 2009-11-25 Normal 180 Day Track No User Fee
S063 2009-11-16 30-day Notice
S062 2009-10-02 135 Review Track For 30-day Notice
S061 2009-09-28 30-day Notice
S060
S059 2009-09-14 Real-time Process
S058 2009-08-28 30-day Notice
S057 2009-06-18 30-day Notice
S056 2009-06-10 30-day Notice
S055 2009-05-14 30-day Notice
S054 2009-01-30 30-day Notice
S053 2009-01-22 Normal 180 Day Track
S052 2008-12-31 Real-time Process
S051 2008-12-19 30-day Notice
S050 2008-12-18 30-day Notice
S049 2008-11-07 30-day Notice
S048 2008-10-14 30-day Notice
S047 2008-09-02 30-day Notice
S046 2008-08-04 135 Review Track For 30-day Notice
S045 2008-07-30 Real-time Process
S044 2008-06-13 30-day Notice
S043 2008-06-02 Real-time Process
S042 2008-05-21 30-day Notice
S041 2008-03-25 Real-time Process
S040 2008-02-15 Normal 180 Day Track No User Fee
S039 2008-02-01 Normal 180 Day Track No User Fee
S038 2007-11-13 30-day Notice
S037 2007-10-24 Real-time Process
S036 2007-10-19 Normal 180 Day Track No User Fee
S035 2007-09-28 30-day Notice
S034 2007-09-21 Real-time Process
S033 2007-06-01 135 Review Track For 30-day Notice
S032 2007-05-16 30-day Notice
S031 2007-04-23 Normal 180 Day Track
S030 2007-04-17 30-day Notice
S029 2007-04-13 Real-time Process
S028 2007-04-06 Real-time Process
S027 2006-10-23 30-day Notice
S026 2006-10-20 Real-time Process
S025 2006-10-12 Real-time Process
S024 2006-10-06 Real-time Process
S023 2006-09-27 30-day Notice
S022 2006-09-25 30-day Notice
S021 2006-09-13 30-day Notice
S020 2006-09-07 30-day Notice
S019 2006-08-16 Real-time Process
S018 2006-07-18 30-day Notice
S017 2006-07-13 30-day Notice
S016 2006-06-07 Real-time Process
S015 2006-05-15 30-day Notice
S014
S013
S012 2006-03-30 Real-time Process
S011 2006-03-07 Real-time Process
S010 2006-02-21 Real-time Process
S009 2006-02-17 Normal 180 Day Track
S008 2006-02-03 Real-time Process
S007 2006-01-25 Normal 180 Day Track
S006 2006-01-06 Real-time Process
S005
S004
S003 2004-09-30 Panel Track
S002 2004-08-13 Normal 180 Day Track No User Fee
S001 2004-07-21 Real-time Process

NIH GUDID Devices

Device IDPMASupp
05414734502948 P030035 001
H758PM311001 P030035 053
05414734503785 P030035 053
05414734507882 P030035 108
05414734507899 P030035 108
05414734507905 P030035 108
05414734507912 P030035 108
05414734509084 P030035 138
05414734509091 P030035 138
05414734510080 P030035 171
05414734510097 P030035 171

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