Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name model 5867 as anchoring sleeve kit and is intended for use with the medtronic implantable endocardial lead families listed.
| Device | SELECT SECURE |
| Classification Name | Permanent Defibrillator Electrodes |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2009-03-17 |
| Decision Date | 2009-04-28 |
| PMA | P030036 |
| Supplement | S013 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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