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.
To update the manufacturing execution system to factoryworks release 9. 8
| Device | Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead |
| Generic Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2020-11-24 |
| Decision Date | 2020-12-15 |
| PMA | P080006 |
| Supplement | S153 |
| Product Code | OJX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080006 | Original Filing | |
| 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 |