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.
Device | VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 |
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 | 2017-07-24 |
Decision Date | 2017-09-21 |
PMA | P030005 |
Supplement | S157 |
Product Code | NKE |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
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 |
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 |
Device ID | PMA | Supp |
---|---|---|
00802526536670 | P030005 | 092 |
00802526536663 | P030005 | 092 |
00802526536632 | P030005 | 099 |
00802526536625 | P030005 | 099 |
00802526559402 | P030005 | 113 |
00802526559389 | P030005 | 113 |
00802526559471 | P030005 | 138 |
00802526559457 | P030005 | 138 |
00802526559426 | P030005 | 138 |