Approval for: 1) replacement of the polymide tubing with polyetheretherktone (peek) tubing on the pulse generator pg header assemblies; 2) the use of a combination of natural and colorized peek to assist manufacturing operators; and 3) the addition of an extra plasma cleaning step to ensure that the bond formed between the medical adhesive applied to the base of the wire and the peek insulation is strong.
| Device | INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS |
| 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 | 2008-11-26 |
| Decision Date | 2009-01-23 |
| PMA | P030005 |
| Supplement | S055 |
| 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 |
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