Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions.
| Device | CONTAK RENEWAL TR |
| 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 | 2005-10-03 |
| Decision Date | 2005-12-21 |
| PMA | P030005 |
| Supplement | S021 |
| 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 | 135 Review Track For 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 |
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