MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD

Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode

FDA Premarket Approval P080006

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.

Pre-market Approval Supplement Details

Approval for the attain ability model 4196 lead. The attain ability model 4196 steroid eluting, dual electrode, is-1transvenous lead is indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible medtronic cardiac resynchronization therapy (crt) system. Extended bipolar pacing is available using this lead in combination with a compatible crt-d system and rv defibrillation lead or with a compatible crt-p system and rv pacing lead.

DeviceMEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
Classification NameDrug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
Generic NameDrug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
ApplicantMEDTRONIC Inc.
Date Received2008-03-14
Decision Date2009-04-07
Notice Date2009-04-10
PMAP080006
SupplementS
Product CodeOJX
Docket Number09M-0182
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P080006Original Filing
S173 2022-11-16 30-day Notice
S172 2022-05-20 30-day Notice
S171 2022-04-27 30-day Notice
S170 2022-04-14 30-day Notice
S169 2022-02-16 30-day Notice
S168 2022-01-13 30-day Notice
S167 2021-12-02 30-day Notice
S166 2021-11-19 30-day Notice
S165
S164
S163 2021-10-07 30-day Notice
S162 2021-08-09 30-day Notice
S161 2021-06-15 30-day Notice
S160 2021-03-16 30-day Notice
S159 2021-02-10 30-day Notice
S158 2021-02-05 30-day Notice
S157 2021-01-12 30-day Notice
S156 2020-12-17 Normal 180 Day Track No User Fee
S155 2020-12-01 30-day Notice
S154 2020-11-25 30-day Notice
S153 2020-11-24 30-day Notice
S152 2020-10-23 30-day Notice
S151 2020-09-17 30-day Notice
S150 2020-07-09 30-day Notice
S149 2020-06-26 30-day Notice
S148 2020-06-16 30-day Notice
S147
S146 2020-02-20 30-day Notice
S145
S144 2019-12-05 30-day Notice
S143 2019-11-18 30-day Notice
S142
S141 2019-10-17 30-day Notice
S140 2019-09-16 30-day Notice
S139 2019-07-12 Normal 180 Day Track No User Fee
S138 2019-07-01 30-day Notice
S137
S136 2019-06-20 30-day Notice
S135 2019-06-10 30-day Notice
S134 2019-05-31 30-day Notice
S133 2019-05-02 Normal 180 Day Track No User Fee
S132 2019-04-15 30-day Notice
S131 2019-02-28 30-day Notice
S130 2019-02-04 30-day Notice
S129 2018-10-26 Normal 180 Day Track
S128 2018-10-23 30-day Notice
S127 2018-10-18 30-day Notice
S126 2018-09-26 30-day Notice
S125 2018-06-20 30-day Notice
S124 2018-06-05 30-day Notice
S123 2018-06-01 30-day Notice
S122 2018-05-15 30-day Notice
S121 2018-04-13 Normal 180 Day Track
S120 2018-04-09 30-day Notice
S119 2018-03-28 30-day Notice
S118 2018-02-22 30-day Notice
S117 2017-12-21 30-day Notice
S116 2017-11-20 30-day Notice
S115 2017-08-31 30-day Notice
S114 2017-08-31 Normal 180 Day Track No User Fee
S113 2017-08-07 30-day Notice
S112 2017-06-28 30-day Notice
S111 2017-06-27 30-day Notice
S110 2017-06-23 30-day Notice
S109 2017-06-07 30-day Notice
S108 2017-01-25 30-day Notice
S107 2017-01-25 Real-time Process
S106 2017-01-17 30-day Notice
S105 2016-12-06 Normal 180 Day Track
S104 2016-11-28 30-day Notice
S103 2016-11-14 30-day Notice
S102 2016-11-10 30-day Notice
S101 2016-11-02 Normal 180 Day Track
S100 2016-10-05 30-day Notice
S099 2016-09-12 30-day Notice
S098 2016-09-02 30-day Notice
S097 2016-08-25 30-day Notice
S096 2016-06-24 30-day Notice
S095 2016-06-03 Real-time Process
S094 2016-06-02 30-day Notice
S093 2016-05-03 Normal 180 Day Track
S092 2016-05-03 30-day Notice
S091 2016-03-21 30-day Notice
S090 2016-03-11 Normal 180 Day Track
S089 2016-03-01 Normal 180 Day Track
S088 2016-01-19 30-day Notice
S087 2015-12-28 30-day Notice
S086 2015-12-22 30-day Notice
S085 2015-09-24 Normal 180 Day Track
S084 2015-09-10 30-day Notice
S083
S082 2015-06-02 30-day Notice
S081 2015-04-30 Normal 180 Day Track No User Fee
S080 2015-04-20 30-day Notice
S079 2015-04-17 30-day Notice
S078 2015-04-03 30-day Notice
S077 2015-03-12 30-day Notice
S076 2015-02-09 30-day Notice
S075 2014-10-15 30-day Notice
S074 2014-09-17 30-day Notice
S073 2014-09-09 Normal 180 Day Track
S072 2014-08-27 30-day Notice
S071 2014-08-22 30-day Notice
S070 2014-08-08 30-day Notice
S069 2014-07-24 30-day Notice
S068 2014-04-01 Normal 180 Day Track
S067 2014-02-27 30-day Notice
S066 2014-01-22 30-day Notice
S065 2013-12-24 30-day Notice
S064 2013-12-19 30-day Notice
S063 2013-11-27 Normal 180 Day Track
S062 2013-11-26 30-day Notice
S061 2013-11-22 30-day Notice
S060 2013-10-30 30-day Notice
S059 2013-10-24 30-day Notice
S058 2013-09-30 30-day Notice
S057 2013-08-13 Normal 180 Day Track No User Fee
S056 2013-07-25 30-day Notice
S055 2013-05-21 30-day Notice
S054 2013-05-17 Real-time Process
S053 2013-04-30 30-day Notice
S052 2013-04-10 Normal 180 Day Track No User Fee
S051 2013-03-22 30-day Notice
S050 2013-03-20 30-day Notice
S049 2012-12-10 30-day Notice
S048 2012-11-29 30-day Notice
S047 2012-11-21 30-day Notice
S046 2012-10-22 30-day Notice
S045 2012-09-28 30-day Notice
S044 2012-09-04 30-day Notice
S043 2012-08-21 30-day Notice
S042 2012-08-03 30-day Notice
S041 2012-06-11 30-day Notice
S040 2012-02-29 30-day Notice
S039 2012-02-23 30-day Notice
S038 2012-02-13 30-day Notice
S037 2011-11-25 30-day Notice
S036 2011-11-21 Normal 180 Day Track
S035 2011-10-24 135 Review Track For 30-day Notice
S034 2011-07-16 30-day Notice
S033 2011-07-08 30-day Notice
S032 2011-06-28 30-day Notice
S031 2011-06-13 30-day Notice
S030 2011-06-08 30-day Notice
S029 2011-06-08 135 Review Track For 30-day Notice
S028 2011-05-13 30-day Notice
S027 2011-05-09 30-day Notice
S026 2011-05-03 30-day Notice
S025 2011-04-26 30-day Notice
S024 2011-04-25 30-day Notice
S023 2011-04-22 30-day Notice
S022 2011-04-07 30-day Notice
S021 2011-03-22 135 Review Track For 30-day Notice
S020 2011-02-28 30-day Notice
S019 2010-12-21 30-day Notice
S018 2010-11-12 30-day Notice
S017 2010-10-26 30-day Notice
S016 2010-10-14 30-day Notice
S015
S014 2010-08-23 Normal 180 Day Track No User Fee
S013 2010-07-15 30-day Notice
S012 2010-07-15 30-day Notice
S011 2010-07-06 30-day Notice
S010 2010-06-28 135 Review Track For 30-day Notice
S009 2010-06-09 30-day Notice
S008 2010-05-17 30-day Notice
S007 2010-03-29 30-day Notice
S006 2010-01-29 Normal 180 Day Track No User Fee
S005 2009-10-30 Normal 180 Day Track
S004 2009-10-19 Normal 180 Day Track
S003 2009-10-08 Real-time Process
S002 2009-06-10 Normal 180 Day Track
S001 2009-04-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00613994469731 P080006 000
00613994719171 P080006 002
00613994719133 P080006 002
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00643169860421 P080006 129
00643169860414 P080006 129

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