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 | Medtronic SelectSecure™ MRI SureScan™ Lead |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP030036 Supplement NumberS139 Date Received07/22/2022 Decision Date10/03/2022 Product Code NVN Advisory Committee Cardiovascular Clinical TrialsNCT01524276 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-07-22 |
| Decision Date | 2022-10-03 |
| PMA | P030036 |
| Supplement | S139 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 PMA NumberP030036 Supplement NumberS139 Date Received07/22/2022 Decision Date10/03/2022 Product Code NVN Advisory Committee Cardiovascular Clinical TrialsNCT01524276 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval To Expand The Indications For Use For The Medtronic SelectSecure MRI SureScan Lead Model 3830 To Include Pacing At The Left Bundle Branch Area As An Alternative To Right Ventricular Pacing. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030036 | Original Filing | |
| S141 | 2022-11-21 | 30-day Notice |
| S140 | 2022-11-16 | 30-day Notice |
| S139 | 2022-07-22 | Normal 180 Day Track |
| S138 | 2022-05-20 | 30-day Notice |
| S137 | 2022-04-14 | 30-day Notice |
| S136 | 2022-02-16 | 30-day Notice |
| S135 | 2022-01-28 | 30-day Notice |
| S134 | 2021-11-19 | 30-day Notice |
| S133 | 2021-11-18 | 30-day Notice |
| S132 | 2021-08-13 | 30-day Notice |
| S131 | 2021-08-09 | 30-day Notice |
| S130 | 2021-02-05 | 30-day Notice |
| S129 | 2021-01-12 | 30-day Notice |
| S128 | 2020-12-01 | 30-day Notice |
| S127 | ||
| S126 | 2020-11-18 | 30-day Notice |
| S125 | 2020-11-13 | 30-day Notice |
| S124 | 2020-10-23 | 30-day Notice |
| S123 | 2020-09-17 | 30-day Notice |
| S122 | 2020-07-09 | 30-day Notice |
| S121 | 2020-06-26 | 30-day Notice |
| S120 | 2020-05-04 | 30-day Notice |
| S119 | ||
| S118 | 2020-02-20 | 30-day Notice |
| S117 | 2020-01-17 | 30-day Notice |
| S116 | 2019-12-17 | 30-day Notice |
| S115 | 2019-11-18 | 30-day Notice |
| S114 | ||
| S113 | 2019-08-22 | 30-day Notice |
| S112 | 2019-07-01 | 30-day Notice |
| S111 | ||
| S110 | 2019-06-10 | 30-day Notice |
| S109 | 2019-05-06 | 30-day Notice |
| S108 | 2019-02-28 | 30-day Notice |
| S107 | 2018-11-02 | 30-day Notice |
| S106 | ||
| S105 | 2018-10-23 | 30-day Notice |
| S104 | 2018-10-18 | 30-day Notice |
| S103 | 2018-09-26 | 30-day Notice |
| S102 | 2018-06-01 | 30-day Notice |
| S101 | 2018-05-15 | 30-day Notice |
| S100 | 2018-04-13 | Normal 180 Day Track |
| S099 | 2018-02-22 | 30-day Notice |
| S098 | 2017-12-04 | Real-time Process |
| S097 | 2017-11-20 | 30-day Notice |
| S096 | 2017-08-07 | 30-day Notice |
| S095 | 2017-05-18 | Normal 180 Day Track |
| S094 | 2017-04-03 | Normal 180 Day Track |
| S093 | 2017-01-25 | Real-time Process |
| S092 | 2016-12-06 | Normal 180 Day Track |
| S091 | 2016-12-06 | Normal 180 Day Track |
| S090 | 2016-11-28 | 30-day Notice |
| S089 | 2016-11-14 | 30-day Notice |
| S088 | 2016-11-02 | Normal 180 Day Track |
| S087 | 2016-10-05 | 30-day Notice |
| S086 | 2016-07-18 | 30-day Notice |
| S085 | 2016-06-24 | 30-day Notice |
| S084 | 2015-12-28 | 30-day Notice |
| S083 | 2015-12-28 | 30-day Notice |
| S082 | 2015-12-23 | Normal 180 Day Track |
| S081 | 2015-12-22 | 30-day Notice |
| S080 | 2015-10-23 | 30-day Notice |
| S079 | 2015-07-20 | 30-day Notice |
| S078 | 2015-04-17 | 30-day Notice |
| S077 | 2015-02-09 | 30-day Notice |
| S076 | 2015-01-21 | 30-day Notice |
| S075 | ||
| S074 | 2014-08-27 | 30-day Notice |
| S073 | 2014-08-08 | 30-day Notice |
| S072 | 2014-07-24 | 30-day Notice |
| S071 | 2014-02-27 | 30-day Notice |
| S070 | 2014-01-29 | 30-day Notice |
| S069 | 2013-12-24 | 30-day Notice |
| S068 | 2013-12-19 | 30-day Notice |
| S067 | 2013-11-22 | 30-day Notice |
| S066 | 2013-10-30 | 30-day Notice |
| S065 | 2013-10-24 | 30-day Notice |
| S064 | 2013-09-30 | 30-day Notice |
| S063 | 2013-09-26 | 30-day Notice |
| S062 | 2013-09-17 | 30-day Notice |
| S061 | 2013-09-13 | 30-day Notice |
| S060 | ||
| S059 | 2013-05-21 | 30-day Notice |
| S058 | 2013-05-17 | Real-time Process |
| S057 | 2013-04-30 | 30-day Notice |
| S056 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S055 | 2013-03-22 | 30-day Notice |
| S054 | 2013-03-20 | 30-day Notice |
| S053 | 2013-02-01 | Special (immediate Track) |
| S052 | 2012-11-21 | 30-day Notice |
| S051 | 2012-10-26 | Real-time Process |
| S050 | 2012-10-22 | 30-day Notice |
| S049 | 2012-09-28 | 30-day Notice |
| S048 | 2012-09-21 | 30-day Notice |
| S047 | 2012-09-04 | 30-day Notice |
| S046 | 2012-08-03 | 30-day Notice |
| S045 | 2012-07-13 | 30-day Notice |
| S044 | 2012-06-20 | 30-day Notice |
| S043 | 2012-06-11 | 30-day Notice |
| S042 | 2012-03-09 | 30-day Notice |
| S041 | 2012-02-29 | 30-day Notice |
| S040 | 2012-02-06 | Normal 180 Day Track No User Fee |
| S039 | 2011-12-09 | 135 Review Track For 30-day Notice |
| S038 | 2011-11-25 | 30-day Notice |
| S037 | 2011-11-21 | Normal 180 Day Track |
| S036 | 2011-07-18 | 30-day Notice |
| S035 | 2011-07-08 | 30-day Notice |
| S034 | 2011-06-28 | 30-day Notice |
| S033 | 2011-06-08 | 30-day Notice |
| S032 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S031 | ||
| S030 | 2011-04-26 | 30-day Notice |
| S029 | 2011-04-22 | 30-day Notice |
| S028 | 2011-04-12 | 30-day Notice |
| S027 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S026 | 2011-02-28 | 30-day Notice |
| S025 | 2010-11-12 | 30-day Notice |
| S024 | 2010-10-26 | 30-day Notice |
| S023 | ||
| S022 | 2010-07-30 | Normal 180 Day Track No User Fee |
| S021 | 2010-07-15 | 30-day Notice |
| S020 | 2010-07-15 | 30-day Notice |
| S019 | 2010-07-15 | 30-day Notice |
| S018 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S017 | 2010-06-09 | 30-day Notice |
| S016 | 2010-03-29 | 30-day Notice |
| S015 | 2010-01-19 | 30-day Notice |
| S014 | 2010-01-15 | Real-time Process |
| S013 | 2009-03-17 | Real-time Process |
| S012 | 2009-02-05 | 30-day Notice |
| S011 | 2008-12-11 | 30-day Notice |
| S010 | 2008-11-03 | 30-day Notice |
| S009 | 2008-08-22 | 135 Review Track For 30-day Notice |
| S008 | 2008-07-31 | 30-day Notice |
| S007 | 2008-06-17 | 30-day Notice |
| S006 | 2008-04-14 | 30-day Notice |
| S005 | 2008-03-24 | 30-day Notice |
| S004 | 2007-12-31 | Normal 180 Day Track |
| S003 | 2007-02-26 | 135 Review Track For 30-day Notice |
| S002 | 2006-09-07 | Special (immediate Track) |
| S001 | 2006-05-10 | 135 Review Track For 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00885074407968 | P030036 | 000 |
| 00613994520784 | P030036 | 000 |
| 00613994119957 | P030036 | 000 |
| 00885074406428 | P030036 | 000 |
| 00613994567611 | P030036 | 013 |
| 00613994726117 | P030036 | 022 |
| 00643169279186 | P030036 | 040 |
| 00643169279193 | P030036 | 040 |
| 00643169279209 | P030036 | 040 |
| 00643169279292 | P030036 | 040 |
| 00643169535848 | P030036 | 073 |
| 00643169535855 | P030036 | 073 |
| 00643169535879 | P030036 | 073 |
| 00643169535886 | P030036 | 073 |
| 00643169857674 | P030036 | 088 |
| 00643169857698 | P030036 | 088 |
| 00643169857681 | P030036 | 088 |
| 00763000130794 | P030036 | 100 |
| 00763000130800 | P030036 | 100 |
| 00763000130817 | P030036 | 100 |
| 00763000740276 | P030036 | 139 |
| 00763000740269 | P030036 | 139 |
| 00763000740252 | P030036 | 139 |