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.
Approval for the medtronic(r) model 7250 jewel(r) af implantable cardioverter defibrillator system, medtronic model 9465 incheck(tm) patients assistant and the medtronic transvene(r) cs/svc model 6937a lead. The system is intended to provide pacing, cardioversion and defibrillation for treatment of patients with symptomatic drug refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias.
| Device | JEWEL AF SYSTEM |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2000-06-15 |
| Decision Date | 2001-04-06 |
| Notice Date | 2001-06-06 |
| PMA | P980050 |
| Supplement | S001 |
| Product Code | LWS |
| Docket Number | 01M-0254 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |
| 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 |