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, PG VISIONIST CRT-P |
| 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 NumberS218 Date Received06/29/2022 Decision Date07/13/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-07-13 |
| PMA | P030005 |
| Supplement | S218 |
| 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 NumberS218 Date Received06/29/2022 Decision Date07/13/2022 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 Ansell Nitrile Gloves As An Alternative Glove For Use During Cardiac Rhythm Management (CRM) Pulse Generator Manufacturing At The St. Paul Site |
| 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 |