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 gem iii at with app, device model 7276 and software model 9974. The device is indicated as follows: the model 7276 gem iii at with app is indicated for use in icd patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation, and/or life threatening ventricular tachyarrhythmias. Atrial rhythm management features such as atrial rate stabilization (ars), atrial preference pacing (app) and post mode switch overdrive (pmop) are indicated for the suppression of atrial tachyarrhythmias in icd-indicated patients with atrial septal lead placement and one or more of the above icd indications. Notes: the use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. The effectiveness of high frequency burst pacing (atrial-50 hz burst therapy) in terminating device classified atrial tachycardia (at) was found to be 17%, and in terminating device classified atrial fibrillation (af) was found to be 16. 8%, in the vt/at patient population studied. The effectiveness of high frequency burst pacing (atrial-50 hz burst therapy) in terminating device classified atrial tachycardia (at) was found to be 11. 7%, and in terminating device classified atrial fibrillation (af) was found to be 18. 2%, in the af-only patient population studied.
| Device | MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974 |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2003-12-12 |
| Decision Date | 2004-04-12 |
| PMA | P980050 |
| Supplement | S015 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street ms Mvs11 mounds View, MN 55112 |
| 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 |