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 | SelectSecure 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 NumberS141 Date Received11/21/2022 Decision Date11/28/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-11-21 |
Decision Date | 2022-11-28 |
PMA | P030036 |
Supplement | S141 |
Product Code | NVN |
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 CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 PMA NumberP030036 Supplement NumberS141 Date Received11/21/2022 Decision Date11/28/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement to Implement A Mechanical De-gating Fixture And To Update In-process Inspections At A Direct Supplier |
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 |