JEWEL AF, GEMM III AT FAMILY OF ICD'S

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P980050 S027

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.

Pre-market Approval Supplement Details

Approval for software enhancements to the medtronic model 9986 desktop boss (version 1. 6) for the medtronic model 2090 carelink programmer for all currently approved medtronic and vitatron pacemaker and icd models.

DeviceJEWEL AF, GEMM III AT FAMILY OF ICD'S
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantMEDTRONIC Inc.
Date Received2007-03-09
Decision Date2007-05-03
PMAP980050
SupplementS027
Product CodeLWS
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street ms Mvs11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P980050Original 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

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