This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the medtronic(r) jewel(r) af 7250 dual chamber implantable cardioverter defibrillator (icd), model 9961 programmer application software, and medtronic(r) sprint(tm) model 6943 steroid eluting, screw-in, atrial/ventricular lead. This system is indicated for use in icd patients either with atrial tachyarrhythmias or who are at significant risk of developing atrial tachyarrhythmias. Patients indicated for an icd are those patients who are at risk of sudden death due to ventricular...
| Device | MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 1998-12-24 |
| Decision Date | 2000-06-14 |
| Notice Date | 2000-07-12 |
| PMA | P980050 |
| Supplement | S |
| Product Code | LWS |
| Docket Number | 00M-1389 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street ms Mvs11 mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980050 | Original Filing | |
| S139 | 2022-11-16 | 30-day Notice |
| S138 | 2022-05-20 | 30-day Notice |
| S137 | 2022-04-14 | 30-day Notice |
| S136 | 2021-11-18 | 30-day Notice |
| S135 | ||
| S134 | 2021-08-09 | 30-day Notice |
| S133 | 2021-06-15 | 30-day Notice |
| S132 | 2021-02-05 | 30-day Notice |
| S131 | 2020-12-01 | 30-day Notice |
| S130 | ||
| S129 | 2020-10-23 | 30-day Notice |
| S128 | 2020-07-09 | 30-day Notice |
| S127 | 2020-06-26 | 30-day Notice |
| S126 | 2020-03-23 | Real-time Process |
| S125 | 2019-12-17 | 30-day Notice |
| S124 | 2019-11-18 | 30-day Notice |
| S123 | ||
| S122 | 2019-06-10 | 30-day Notice |
| S121 | 2019-02-28 | 30-day Notice |
| S120 | 2018-10-18 | 30-day Notice |
| S119 | 2018-06-20 | 30-day Notice |
| S118 | 2018-06-01 | 30-day Notice |
| S117 | 2018-05-15 | 30-day Notice |
| S116 | 2018-04-09 | 30-day Notice |
| S115 | 2018-03-28 | 30-day Notice |
| S114 | 2018-02-22 | 30-day Notice |
| S113 | 2017-11-20 | 30-day Notice |
| S112 | 2017-06-28 | 30-day Notice |
| S111 | 2017-06-23 | 30-day Notice |
| S110 | 2017-06-07 | 30-day Notice |
| S109 | 2017-01-17 | 30-day Notice |
| S108 | 2016-11-14 | 30-day Notice |
| S107 | 2016-10-05 | 30-day Notice |
| S106 | 2016-09-02 | 30-day Notice |
| S105 | 2016-06-24 | 30-day Notice |
| S104 | 2016-06-01 | Normal 180 Day Track |
| S103 | 2015-12-28 | 30-day Notice |
| S102 | 2015-12-22 | 30-day Notice |
| S101 | 2015-07-02 | Real-time Process |
| S100 | 2015-04-17 | 30-day Notice |
| S099 | 2015-04-14 | Real-time Process |
| S098 | 2015-02-09 | 30-day Notice |
| S097 | 2014-12-22 | Normal 180 Day Track |
| S096 | 2014-08-27 | 30-day Notice |
| S095 | 2014-08-13 | 30-day Notice |
| S094 | 2014-08-08 | 30-day Notice |
| S093 | 2014-07-24 | 30-day Notice |
| S092 | 2014-07-02 | Real-time Process |
| S091 | 2014-02-27 | 30-day Notice |
| S090 | 2013-12-24 | 30-day Notice |
| S089 | 2013-12-19 | 30-day Notice |
| S088 | 2013-11-27 | 30-day Notice |
| S087 | 2013-10-30 | 30-day Notice |
| S086 | 2013-10-24 | 30-day Notice |
| S085 | 2013-09-30 | 30-day Notice |
| S084 | 2013-05-17 | Real-time Process |
| S083 | 2013-04-30 | 30-day Notice |
| S082 | 2013-04-18 | Real-time Process |
| S081 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S080 | 2013-03-22 | 30-day Notice |
| S079 | 2012-11-21 | 30-day Notice |
| S078 | 2012-09-28 | 30-day Notice |
| S077 | 2012-09-04 | 30-day Notice |
| S076 | 2012-08-07 | Normal 180 Day Track |
| S075 | 2012-08-03 | 30-day Notice |
| S074 | 2012-06-11 | 30-day Notice |
| S073 | 2012-04-04 | Real-time Process |
| S072 | 2012-03-26 | Real-time Process |
| S071 | 2012-02-29 | 30-day Notice |
| S070 | 2012-02-22 | Real-time Process |
| S069 | 2011-11-25 | 30-day Notice |
| S068 | 2011-11-21 | Normal 180 Day Track |
| S067 | 2011-09-19 | Real-time Process |
| S066 | 2011-07-18 | 30-day Notice |
| S065 | 2011-07-08 | 30-day Notice |
| S064 | 2011-06-28 | 30-day Notice |
| S063 | 2011-06-08 | 30-day Notice |
| S062 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S061 | 2011-04-26 | 30-day Notice |
| S060 | 2011-04-12 | 30-day Notice |
| S059 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S058 | 2011-02-28 | 30-day Notice |
| S057 | 2011-01-04 | Normal 180 Day Track |
| S056 | 2010-11-12 | 30-day Notice |
| S055 | 2010-10-26 | 30-day Notice |
| S054 | ||
| S053 | 2010-07-15 | 30-day Notice |
| S052 | 2010-07-15 | 30-day Notice |
| S051 | 2010-07-15 | 30-day Notice |
| S050 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S049 | 2010-05-20 | Real-time Process |
| S048 | 2010-03-29 | 30-day Notice |
| S047 | 2010-03-01 | Real-time Process |
| S046 | 2010-01-19 | 30-day Notice |
| S045 | 2010-01-15 | Real-time Process |
| S044 | 2009-12-30 | Normal 180 Day Track No User Fee |
| S043 | 2009-12-16 | Normal 180 Day Track No User Fee |
| S042 | 2009-06-17 | Real-time Process |
| S041 | 2009-03-02 | Normal 180 Day Track |
| S040 | 2009-02-05 | 30-day Notice |
| S039 | 2008-12-11 | 30-day Notice |
| S038 | 2008-11-03 | 30-day Notice |
| S037 | 2008-10-17 | Real-time Process |
| S036 | 2008-08-11 | 30-day Notice |
| S035 | 2008-07-28 | Normal 180 Day Track |
| S034 | 2008-06-17 | 30-day Notice |
| S033 | 2008-04-14 | 30-day Notice |
| S032 | 2008-03-21 | 30-day Notice |
| S031 | 2007-10-11 | 30-day Notice |
| S030 | 2007-09-28 | Normal 180 Day Track |
| S029 | 2007-09-17 | 135 Review Track For 30-day Notice |
| S028 | 2007-05-31 | 30-day Notice |
| S027 | 2007-03-09 | Real-time Process |
| S026 | 2007-03-12 | 135 Review Track For 30-day Notice |
| S025 | 2006-10-17 | 30-day Notice |
| S024 | 2006-06-12 | Normal 180 Day Track No User Fee |
| S023 | 2006-05-10 | 135 Review Track For 30-day Notice |
| S022 | 2006-02-21 | Real-time Process |
| S021 | 2006-02-14 | Real-time Process |
| S020 | 2005-12-09 | Normal 180 Day Track |
| S019 | 2005-12-08 | Real-time Process |
| S018 | ||
| S017 | ||
| S016 | 2004-06-18 | Normal 180 Day Track No User Fee |
| S015 | 2003-12-12 | Real-time Process |
| S014 | 2003-08-22 | Normal 180 Day Track No User Fee |
| S013 | 2002-12-03 | Normal 180 Day Track |
| S012 | 2002-02-27 | Normal 180 Day Track |
| S011 | 2001-12-18 | Real-time Process |
| S010 | 2001-11-05 | Special (immediate Track) |
| S009 | 2001-09-24 | 30-day Notice |
| S008 | ||
| S007 | 2001-07-17 | 30-day Notice |
| S006 | 2001-06-27 | Normal 180 Day Track |
| S005 | 2001-06-14 | Normal 180 Day Track |
| S004 | 2001-04-13 | Real-time Process |
| S003 | 2001-02-05 | Normal 180 Day Track |
| S002 | 2000-11-06 | Real-time Process |
| S001 | 2000-06-15 | Panel Track |