Approval for the frontier cardiac resynchronization therapy system. These devices are indicated for: 1) maintaining synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic atrial fibrillation and have nyha class ii or iii heart failure. 2) the reduction of the symptoms of moderate to severe heart failure (nyha class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction
| Device | FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS |
| 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 | 2004-09-30 |
| Decision Date | 2005-04-29 |
| Notice Date | 2005-07-26 |
| PMA | P030035 |
| Supplement | S003 |
| Product Code | NKE |
| Docket Number | 05M-0289 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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