To implement two new inspection processes
| Device | Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2019-12-09 |
| Decision Date | 2020-01-06 |
| PMA | P030035 |
| Supplement | S179 |
| Product Code | NKE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030035 | | Original Filing |
| S191 |
2022-07-27 |
Real-time Process |
| S190 |
2022-07-01 |
30-day Notice |
| S189 |
2022-03-07 |
Real-time Process |
| S188 |
2021-10-18 |
Real-time Process |
| S187 |
2021-06-28 |
30-day Notice |
| S186 |
2021-04-02 |
Real-time Process |
| S185 |
2021-03-12 |
30-day Notice |
| S184 | | |
| S183 |
2020-11-25 |
30-day Notice |
| S182 |
2020-10-21 |
30-day Notice |
| S181 |
2020-04-24 |
30-day Notice |
| 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