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 | SELECTSECURE LEAD |
| Classification Name | Permanent Defibrillator Electrodes |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-23 |
| PMA | P030036 |
| Supplement | S058 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 |
Supplemental Filings
| 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 |
NIH GUDID Devices