Approval for cybersecurity updates to the firmware of low voltage devices, cybersecurity updates to the clinician programmer, and updates to the programmer and merlin. Net server to detect rapid battery depletion in high voltage devices.
| Device | Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
| Classification Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2017-05-17 |
| Decision Date | 2017-08-23 |
| PMA | P030035 |
| Supplement | S157 |
| Product Code | NKE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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