Approval for firmware modifications for the ingenio and accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated programmer software applications to support the addition of features including signal artifact monitor, automatic lead recognition, mri protection mode, and rightrate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and crt p devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.
| Device | INVIVE CRT-P, INTUA CRT-P, VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P, and Programmer Softwa |
| Classification Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | GUIDANT CORP. |
| Date Received | 2018-04-30 |
| Decision Date | 2018-07-27 |
| PMA | P030005 |
| Supplement | S176 |
| Product Code | NKE |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GUIDANT CORP. 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030005 | | Original Filing |
| S227 |
2022-12-12 |
30-day Notice |
| S226 |
2022-12-07 |
30-day Notice |
| S225 |
2022-10-26 |
Real-time Process |
| S224 |
2022-10-05 |
30-day Notice |
| S223 | | |
| S222 | | |
| S221 |
2022-09-20 |
30-day Notice |
| S220 | | |
| S219 |
2022-07-21 |
30-day Notice |
| S218 |
2022-06-29 |
30-day Notice |
| S217 |
2021-12-16 |
30-day Notice |
| S216 |
2021-12-07 |
30-day Notice |
| S215 | | |
| S214 |
2021-10-08 |
30-day Notice |
| S213 |
2021-09-23 |
30-day Notice |
| S212 | | |
| S211 |
2021-06-21 |
Real-time Process |
| S210 |
2021-06-11 |
Real-time Process |
| S209 |
2021-04-28 |
30-day Notice |
| S208 |
2021-04-26 |
30-day Notice |
| S207 |
2021-03-08 |
30-day Notice |
| S206 |
2020-12-08 |
30-day Notice |
| S205 | | |
| S204 |
2020-10-21 |
30-day Notice |
| S203 |
2020-10-01 |
30-day Notice |
| S202 |
2020-09-24 |
30-day Notice |
| S201 |
2020-08-13 |
Real-time Process |
| S200 | | |
| S199 |
2020-08-06 |
30-day Notice |
| S198 |
2020-07-27 |
30-day Notice |
| S197 |
2020-03-20 |
Real-time Process |
| S196 |
2020-03-13 |
30-day Notice |
| S195 |
2020-03-02 |
30-day Notice |
| S194 |
2020-01-27 |
30-day Notice |
| S193 | | |
| S192 |
2019-12-03 |
30-day Notice |
| S191 |
2019-11-22 |
30-day Notice |
| S190 |
2019-10-21 |
30-day Notice |
| S189 |
2019-09-10 |
30-day Notice |
| S188 | | |
| S187 |
2019-07-12 |
30-day Notice |
| S186 | | |
| S185 |
2019-05-31 |
30-day Notice |
| S184 |
2019-04-10 |
Real-time Process |
| S183 |
2019-03-20 |
Real-time Process |
| S182 | | |
| S181 |
2019-02-11 |
30-day Notice |
| S180 | | |
| S179 |
2018-12-03 |
Real-time Process |
| S178 |
2018-10-19 |
30-day Notice |
| S177 | | |
| S176 |
2018-04-30 |
Normal 180 Day Track |
| S175 |
2018-03-26 |
30-day Notice |
| S174 |
2018-02-16 |
30-day Notice |
| S173 |
2018-01-19 |
30-day Notice |
| S172 |
2018-01-18 |
Real-time Process |
| S171 |
2017-12-14 |
Real-time Process |
| S170 |
2017-11-21 |
30-day Notice |
| S169 |
2017-11-21 |
30-day Notice |
| S168 |
2017-11-20 |
30-day Notice |
| S167 |
2017-11-13 |
30-day Notice |
| S166 |
2017-11-02 |
30-day Notice |
| S165 |
2017-10-20 |
Real-time Process |
| S164 |
2017-09-29 |
30-day Notice |
| S163 |
2017-09-28 |
30-day Notice |
| S162 |
2017-09-27 |
30-day Notice |
| S161 |
2017-09-15 |
Real-time Process |
| S160 |
2017-09-05 |
30-day Notice |
| S159 |
2017-08-04 |
30-day Notice |
| S158 |
2017-08-02 |
30-day Notice |
| S157 |
2017-07-24 |
Real-time Process |
| S156 |
2017-07-17 |
Real-time Process |
| S155 |
2017-05-22 |
Real-time Process |
| S154 |
2017-04-07 |
30-day Notice |
| S153 |
2017-04-04 |
30-day Notice |
| S152 |
2017-04-03 |
Normal 180 Day Track |
| S151 |
2017-03-17 |
30-day Notice |
| S150 |
2017-01-30 |
30-day Notice |
| S149 |
2016-12-19 |
30-day Notice |
| S148 |
2016-11-22 |
Real-time Process |
| S147 |
2016-11-18 |
30-day Notice |
| S146 |
2016-11-03 |
30-day Notice |
| S145 |
2016-10-26 |
Normal 180 Day Track |
| S144 |
2016-10-03 |
30-day Notice |
| S143 |
2016-09-12 |
30-day Notice |
| S142 |
2016-09-02 |
30-day Notice |
| S141 |
2016-08-17 |
30-day Notice |
| S140 |
2016-07-15 |
30-day Notice |
| S139 |
2016-07-07 |
30-day Notice |
| S138 |
2016-07-05 |
Normal 180 Day Track |
| S137 |
2016-05-26 |
30-day Notice |
| S136 |
2016-05-04 |
30-day Notice |
| S135 |
2016-04-27 |
30-day Notice |
| S134 |
2016-04-21 |
Real-time Process |
| S133 |
2016-02-17 |
Real-time Process |
| S132 |
2016-01-08 |
30-day Notice |
| S131 |
2015-12-21 |
Real-time Process |
| S130 |
2015-11-04 |
30-day Notice |
| S129 |
2015-08-21 |
Real-time Process |
| S128 |
2015-07-17 |
30-day Notice |
| S127 | | |
| S126 |
2015-06-26 |
30-day Notice |
| S125 |
2015-06-22 |
30-day Notice |
| S124 |
2015-06-18 |
30-day Notice |
| S123 |
2015-05-08 |
30-day Notice |
| S122 |
2015-04-27 |
Real-time Process |
| S121 |
2015-04-24 |
30-day Notice |
| S120 |
2015-04-23 |
30-day Notice |
| S119 |
2015-03-18 |
Real-time Process |
| S118 |
2015-03-02 |
30-day Notice |
| S117 |
2015-02-23 |
30-day Notice |
| S116 |
2015-01-16 |
Real-time Process |
| S115 |
2014-11-20 |
Real-time Process |
| S114 |
2014-10-27 |
30-day Notice |
| S113 |
2014-07-25 |
Normal 180 Day Track |
| S112 |
2014-06-30 |
30-day Notice |
| S111 |
2014-06-09 |
30-day Notice |
| S110 |
2014-05-05 |
30-day Notice |
| S109 |
2014-05-02 |
30-day Notice |
| S108 |
2014-04-14 |
30-day Notice |
| S107 |
2014-03-18 |
Real-time Process |
| S106 |
2014-02-21 |
Real-time Process |
| S105 |
2014-01-30 |
30-day Notice |
| S104 |
2013-10-29 |
30-day Notice |
| S103 |
2013-09-13 |
30-day Notice |
| S102 |
2013-08-29 |
30-day Notice |
| S101 |
2013-07-30 |
30-day Notice |
| S100 |
2013-06-03 |
30-day Notice |
| S099 |
2013-05-22 |
Real-time Process |
| S098 |
2013-05-08 |
30-day Notice |
| S097 |
2013-03-29 |
30-day Notice |
| S096 |
2012-12-21 |
30-day Notice |
| S095 | | |
| S094 |
2012-12-12 |
30-day Notice |
| S093 |
2012-11-08 |
30-day Notice |
| S092 |
2012-10-25 |
Normal 180 Day Track |
| S091 | | |
| S090 |
2012-10-10 |
30-day Notice |
| S089 |
2012-10-01 |
30-day Notice |
| S088 |
2012-09-14 |
Normal 180 Day Track |
| S087 |
2012-09-11 |
30-day Notice |
| S086 |
2012-07-06 |
Real-time Process |
| S085 |
2012-07-06 |
135 Review Track For 30-day Notice |
| S084 |
2012-05-31 |
30-day Notice |
| S083 |
2012-04-27 |
30-day Notice |
| S082 |
2012-03-26 |
30-day Notice |
| S081 |
2012-01-30 |
Real-time Process |
| S080 |
2011-11-21 |
30-day Notice |
| S079 |
2011-07-12 |
Normal 180 Day Track |
| S078 |
2011-06-03 |
30-day Notice |
| S077 |
2011-05-25 |
30-day Notice |
| S076 |
2011-05-06 |
30-day Notice |
| S075 |
2011-04-06 |
30-day Notice |
| S074 |
2011-04-01 |
30-day Notice |
| S073 |
2011-03-18 |
Real-time Process |
| S072 |
2010-12-20 |
30-day Notice |
| S071 |
2010-09-01 |
30-day Notice |
| S070 |
2010-08-23 |
Real-time Process |
| S069 |
2010-08-18 |
30-day Notice |
| S068 |
2010-08-06 |
30-day Notice |
| S067 |
2010-08-05 |
135 Review Track For 30-day Notice |
| S066 | | |
| S065 |
2010-07-15 |
30-day Notice |
| S064 |
2010-04-20 |
30-day Notice |
| S063 |
2010-04-16 |
30-day Notice |
| S062 |
2010-03-08 |
30-day Notice |
| S061 |
2010-02-04 |
30-day Notice |
| S060 |
2009-12-16 |
30-day Notice |
| S059 |
2009-11-19 |
30-day Notice |
| S058 |
2009-05-22 |
135 Review Track For 30-day Notice |
| S057 |
2009-04-21 |
30-day Notice |
| S056 |
2009-02-09 |
30-day Notice |
| S055 |
2008-11-26 |
Real-time Process |
| S054 |
2008-08-29 |
30-day Notice |
| S053 |
2008-06-18 |
30-day Notice |
| S052 |
2008-06-03 |
30-day Notice |
| S051 |
2008-03-03 |
30-day Notice |
| S050 |
2008-02-14 |
Real-time Process |
| S049 |
2007-12-21 |
30-day Notice |
| S048 |
2007-11-09 |
30-day Notice |
| S047 |
2007-09-26 |
30-day Notice |
| S046 |
2007-08-23 |
Normal 180 Day Track |
| S045 | | |
| S044 |
2007-07-13 |
30-day Notice |
| S043 |
2007-03-14 |
30-day Notice |
| S042 |
2007-02-28 |
30-day Notice |
| S041 |
2007-01-17 |
30-day Notice |
| S040 |
2006-11-06 |
30-day Notice |
| S039 |
2006-11-01 |
Real-time Process |
| S038 | | |
| S037 |
2006-06-26 |
30-day Notice |
| S036 | | |
| S035 |
2006-05-12 |
Normal 180 Day Track |
| S034 |
2006-04-13 |
30-day Notice |
| S033 |
2006-03-28 |
30-day Notice |
| S032 |
2006-03-03 |
30-day Notice |
| S031 |
2006-03-03 |
30-day Notice |
| S030 |
2006-03-01 |
30-day Notice |
| S029 |
2005-12-21 |
135 Review Track For 30-day Notice |
| S028 |
2005-12-21 |
30-day Notice |
| S027 |
2005-12-05 |
Real-time Process |
| S026 | | |
| S025 | | |
| S024 |
2005-11-16 |
30-day Notice |
| S023 |
2005-11-03 |
30-day Notice |
| S022 |
2005-10-11 |
135 Review Track For 30-day Notice |
| S021 |
2005-10-03 |
135 Review Track For 30-day Notice |
| S020 |
2005-09-09 |
30-day Notice |
| S019 |
2005-08-29 |
135 Review Track For 30-day Notice |
| S018 |
2005-08-25 |
30-day Notice |
| S017 | | |
| S016 |
2005-08-15 |
30-day Notice |
| S015 |
2005-08-15 |
30-day Notice |
| S014 |
2005-08-15 |
30-day Notice |
| S013 |
2005-08-12 |
30-day Notice |
| S012 |
2005-08-12 |
30-day Notice |
| S011 |
2005-08-11 |
30-day Notice |
| S010 |
2005-06-27 |
30-day Notice |
| S009 |
2005-06-21 |
30-day Notice |
| S008 |
2005-03-18 |
Real-time Process |
| S007 | | |
| S006 |
2004-12-03 |
30-day Notice |
| S005 |
2004-11-22 |
Normal 180 Day Track |
| S004 |
2004-10-21 |
30-day Notice |
| S003 |
2004-06-21 |
Real-time Process |
| S002 |
2004-06-08 |
Special (immediate Track) |
| S001 |
2004-02-04 |
30-day Notice |
NIH GUDID Devices