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 | PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS219 Date Received07/21/2022 Decision Date07/27/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-21 |
| Decision Date | 2022-07-27 |
| PMA | P030005 |
| Supplement | S219 |
| 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 | GUIDANT CORP. 4100 Hamline Avenue North st. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS219 Date Received07/21/2022 Decision Date07/27/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of An Alternate Surge Suppressor Due To A New Second-tier Supplier |
| 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 |