Approval for an increase in the storage shelf life of the tyvek lid component, which includes the adhesive coating, used in the medtronic cardiac rhythm disease management products from 18 months to 48 months.
| Device | ATTAIN ABILITY LEAD |
| Classification Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Generic Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-23 |
| PMA | P080006 |
| Supplement | S054 |
| Product Code | OJX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080006 | | Original Filing |
| S173 |
2022-11-16 |
30-day Notice |
| S172 |
2022-05-20 |
30-day Notice |
| S171 |
2022-04-27 |
30-day Notice |
| S170 |
2022-04-14 |
30-day Notice |
| S169 |
2022-02-16 |
30-day Notice |
| S168 |
2022-01-13 |
30-day Notice |
| S167 |
2021-12-02 |
30-day Notice |
| S166 |
2021-11-19 |
30-day Notice |
| S165 | | |
| S164 | | |
| S163 |
2021-10-07 |
30-day Notice |
| S162 |
2021-08-09 |
30-day Notice |
| S161 |
2021-06-15 |
30-day Notice |
| S160 |
2021-03-16 |
30-day Notice |
| S159 |
2021-02-10 |
30-day Notice |
| S158 |
2021-02-05 |
30-day Notice |
| S157 |
2021-01-12 |
30-day Notice |
| S156 |
2020-12-17 |
Normal 180 Day Track No User Fee |
| S155 |
2020-12-01 |
30-day Notice |
| S154 |
2020-11-25 |
30-day Notice |
| S153 |
2020-11-24 |
30-day Notice |
| S152 |
2020-10-23 |
30-day Notice |
| S151 |
2020-09-17 |
30-day Notice |
| S150 |
2020-07-09 |
30-day Notice |
| S149 |
2020-06-26 |
30-day Notice |
| S148 |
2020-06-16 |
30-day Notice |
| S147 | | |
| S146 |
2020-02-20 |
30-day Notice |
| S145 | | |
| S144 |
2019-12-05 |
30-day Notice |
| S143 |
2019-11-18 |
30-day Notice |
| S142 | | |
| S141 |
2019-10-17 |
30-day Notice |
| S140 |
2019-09-16 |
30-day Notice |
| S139 |
2019-07-12 |
Normal 180 Day Track No User Fee |
| S138 |
2019-07-01 |
30-day Notice |
| S137 | | |
| S136 |
2019-06-20 |
30-day Notice |
| S135 |
2019-06-10 |
30-day Notice |
| S134 |
2019-05-31 |
30-day Notice |
| S133 |
2019-05-02 |
Normal 180 Day Track No User Fee |
| S132 |
2019-04-15 |
30-day Notice |
| S131 |
2019-02-28 |
30-day Notice |
| S130 |
2019-02-04 |
30-day Notice |
| S129 |
2018-10-26 |
Normal 180 Day Track |
| S128 |
2018-10-23 |
30-day Notice |
| S127 |
2018-10-18 |
30-day Notice |
| S126 |
2018-09-26 |
30-day Notice |
| S125 |
2018-06-20 |
30-day Notice |
| S124 |
2018-06-05 |
30-day Notice |
| S123 |
2018-06-01 |
30-day Notice |
| S122 |
2018-05-15 |
30-day Notice |
| S121 |
2018-04-13 |
Normal 180 Day Track |
| S120 |
2018-04-09 |
30-day Notice |
| S119 |
2018-03-28 |
30-day Notice |
| S118 |
2018-02-22 |
30-day Notice |
| S117 |
2017-12-21 |
30-day Notice |
| S116 |
2017-11-20 |
30-day Notice |
| S115 |
2017-08-31 |
30-day Notice |
| S114 |
2017-08-31 |
Normal 180 Day Track No User Fee |
| S113 |
2017-08-07 |
30-day Notice |
| S112 |
2017-06-28 |
30-day Notice |
| S111 |
2017-06-27 |
30-day Notice |
| S110 |
2017-06-23 |
30-day Notice |
| S109 |
2017-06-07 |
30-day Notice |
| S108 |
2017-01-25 |
30-day Notice |
| S107 |
2017-01-25 |
Real-time Process |
| S106 |
2017-01-17 |
30-day Notice |
| S105 |
2016-12-06 |
Normal 180 Day Track |
| S104 |
2016-11-28 |
30-day Notice |
| S103 |
2016-11-14 |
30-day Notice |
| S102 |
2016-11-10 |
30-day Notice |
| S101 |
2016-11-02 |
Normal 180 Day Track |
| S100 |
2016-10-05 |
30-day Notice |
| S099 |
2016-09-12 |
30-day Notice |
| S098 |
2016-09-02 |
30-day Notice |
| S097 |
2016-08-25 |
30-day Notice |
| S096 |
2016-06-24 |
30-day Notice |
| S095 |
2016-06-03 |
Real-time Process |
| S094 |
2016-06-02 |
30-day Notice |
| S093 |
2016-05-03 |
Normal 180 Day Track |
| S092 |
2016-05-03 |
30-day Notice |
| S091 |
2016-03-21 |
30-day Notice |
| S090 |
2016-03-11 |
Normal 180 Day Track |
| S089 |
2016-03-01 |
Normal 180 Day Track |
| S088 |
2016-01-19 |
30-day Notice |
| S087 |
2015-12-28 |
30-day Notice |
| S086 |
2015-12-22 |
30-day Notice |
| S085 |
2015-09-24 |
Normal 180 Day Track |
| S084 |
2015-09-10 |
30-day Notice |
| S083 | | |
| S082 |
2015-06-02 |
30-day Notice |
| S081 |
2015-04-30 |
Normal 180 Day Track No User Fee |
| S080 |
2015-04-20 |
30-day Notice |
| S079 |
2015-04-17 |
30-day Notice |
| S078 |
2015-04-03 |
30-day Notice |
| S077 |
2015-03-12 |
30-day Notice |
| S076 |
2015-02-09 |
30-day Notice |
| S075 |
2014-10-15 |
30-day Notice |
| S074 |
2014-09-17 |
30-day Notice |
| S073 |
2014-09-09 |
Normal 180 Day Track |
| S072 |
2014-08-27 |
30-day Notice |
| S071 |
2014-08-22 |
30-day Notice |
| S070 |
2014-08-08 |
30-day Notice |
| S069 |
2014-07-24 |
30-day Notice |
| S068 |
2014-04-01 |
Normal 180 Day Track |
| S067 |
2014-02-27 |
30-day Notice |
| S066 |
2014-01-22 |
30-day Notice |
| S065 |
2013-12-24 |
30-day Notice |
| S064 |
2013-12-19 |
30-day Notice |
| S063 |
2013-11-27 |
Normal 180 Day Track |
| S062 |
2013-11-26 |
30-day Notice |
| S061 |
2013-11-22 |
30-day Notice |
| S060 |
2013-10-30 |
30-day Notice |
| S059 |
2013-10-24 |
30-day Notice |
| S058 |
2013-09-30 |
30-day Notice |
| S057 |
2013-08-13 |
Normal 180 Day Track No User Fee |
| S056 |
2013-07-25 |
30-day Notice |
| S055 |
2013-05-21 |
30-day Notice |
| S054 |
2013-05-17 |
Real-time Process |
| S053 |
2013-04-30 |
30-day Notice |
| S052 |
2013-04-10 |
Normal 180 Day Track No User Fee |
| S051 |
2013-03-22 |
30-day Notice |
| S050 |
2013-03-20 |
30-day Notice |
| S049 |
2012-12-10 |
30-day Notice |
| S048 |
2012-11-29 |
30-day Notice |
| S047 |
2012-11-21 |
30-day Notice |
| S046 |
2012-10-22 |
30-day Notice |
| S045 |
2012-09-28 |
30-day Notice |
| S044 |
2012-09-04 |
30-day Notice |
| S043 |
2012-08-21 |
30-day Notice |
| S042 |
2012-08-03 |
30-day Notice |
| S041 |
2012-06-11 |
30-day Notice |
| S040 |
2012-02-29 |
30-day Notice |
| S039 |
2012-02-23 |
30-day Notice |
| S038 |
2012-02-13 |
30-day Notice |
| S037 |
2011-11-25 |
30-day Notice |
| S036 |
2011-11-21 |
Normal 180 Day Track |
| S035 |
2011-10-24 |
135 Review Track For 30-day Notice |
| S034 |
2011-07-16 |
30-day Notice |
| S033 |
2011-07-08 |
30-day Notice |
| S032 |
2011-06-28 |
30-day Notice |
| S031 |
2011-06-13 |
30-day Notice |
| S030 |
2011-06-08 |
30-day Notice |
| S029 |
2011-06-08 |
135 Review Track For 30-day Notice |
| S028 |
2011-05-13 |
30-day Notice |
| S027 |
2011-05-09 |
30-day Notice |
| S026 |
2011-05-03 |
30-day Notice |
| S025 |
2011-04-26 |
30-day Notice |
| S024 |
2011-04-25 |
30-day Notice |
| S023 |
2011-04-22 |
30-day Notice |
| S022 |
2011-04-07 |
30-day Notice |
| S021 |
2011-03-22 |
135 Review Track For 30-day Notice |
| S020 |
2011-02-28 |
30-day Notice |
| S019 |
2010-12-21 |
30-day Notice |
| S018 |
2010-11-12 |
30-day Notice |
| S017 |
2010-10-26 |
30-day Notice |
| S016 |
2010-10-14 |
30-day Notice |
| S015 | | |
| S014 |
2010-08-23 |
Normal 180 Day Track No User Fee |
| S013 |
2010-07-15 |
30-day Notice |
| S012 |
2010-07-15 |
30-day Notice |
| S011 |
2010-07-06 |
30-day Notice |
| S010 |
2010-06-28 |
135 Review Track For 30-day Notice |
| S009 |
2010-06-09 |
30-day Notice |
| S008 |
2010-05-17 |
30-day Notice |
| S007 |
2010-03-29 |
30-day Notice |
| S006 |
2010-01-29 |
Normal 180 Day Track No User Fee |
| S005 |
2009-10-30 |
Normal 180 Day Track |
| S004 |
2009-10-19 |
Normal 180 Day Track |
| S003 |
2009-10-08 |
Real-time Process |
| S002 |
2009-06-10 |
Normal 180 Day Track |
| S001 |
2009-04-09 |
30-day Notice |
NIH GUDID Devices