HeartWare Ventricular Assist System

FDA Premarket Approval P100047 S168

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

Add controls to existing work instructions to enhance the batteries manufacturing process at inventus power.

DeviceHeartWare Ventricular Assist System
Generic NameVentricular (assist) Bypass
ApplicantMedtronic
Date Received2020-06-29
Decision Date2020-07-20
PMAP100047
SupplementS168
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic 8200 Coral Seast. N.e. mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P100047Original Filing
S168 2020-06-29 30-day Notice
S167 2020-06-19 30-day Notice
S166
S165
S164 2020-05-26 30-day Notice
S163
S162 2020-05-07 30-day Notice
S161 2020-04-10 30-day Notice
S160
S159
S158 2020-03-13 30-day Notice
S157 2020-03-09 30-day Notice
S156 2020-03-05 30-day Notice
S155
S154 2020-02-12 Real-time Process
S153 2020-02-04 30-day Notice
S152 2020-01-27 30-day Notice
S151
S150 2019-11-18 135 Review Track For 30-day Notice
S149
S148 2019-09-27 30-day Notice
S147 2019-09-25 30-day Notice
S146
S145 2019-08-08 30-day Notice
S144
S143 2019-07-26 30-day Notice
S142
S141 2019-06-10 30-day Notice
S140 2019-05-31 30-day Notice
S139
S138
S137 2019-03-04 30-day Notice
S136 2019-02-27 30-day Notice
S135 2019-02-19 Special (immediate Track)
S134
S133 2018-12-17 Normal 180 Day Track No User Fee
S132
S131
S130 2018-09-24 30-day Notice
S129
S128
S127 2018-08-24 30-day Notice
S126 2018-07-13 30-day Notice
S125 2018-06-14 30-day Notice
S124 2018-06-08 Normal 180 Day Track No User Fee
S123 2018-05-31 30-day Notice
S122 2018-05-10 Real-time Process
S121 2018-05-07 30-day Notice
S120 2018-05-02 135 Review Track For 30-day Notice
S119 2018-04-10 30-day Notice
S118 2018-03-15 Special (immediate Track)
S117 2018-01-29 30-day Notice
S116 2017-10-31 30-day Notice
S115 2017-10-30 Normal 180 Day Track No User Fee
S114 2017-10-30 Normal 180 Day Track No User Fee
S113 2017-10-26 30-day Notice
S112 2017-10-10 Normal 180 Day Track
S111 2017-09-28 Normal 180 Day Track
S110 2017-09-25 Normal 180 Day Track
S109 2017-08-28 30-day Notice
S108 2017-08-16 30-day Notice
S107 2017-08-14 30-day Notice
S106 2017-07-31 30-day Notice
S105 2017-07-27 30-day Notice
S104 2017-07-27 30-day Notice
S103 2017-07-20 30-day Notice
S102 2017-07-17 30-day Notice
S101 2017-06-20 Normal 180 Day Track
S100 2017-06-06 30-day Notice
S099 2017-06-05 30-day Notice
S098 2017-06-05 30-day Notice
S097 2017-05-30 30-day Notice
S096 2017-05-30 30-day Notice
S095 2017-05-30 30-day Notice
S094 2017-05-24 30-day Notice
S093 2017-05-22 30-day Notice
S092 2017-05-15 30-day Notice
S091 2017-02-14 30-day Notice
S090 2017-01-31 Panel Track
S089 2016-11-21 135 Review Track For 30-day Notice
S088 2016-11-18 30-day Notice
S087 2016-11-17 30-day Notice
S086 2016-10-31 30-day Notice
S085 2016-10-06 30-day Notice
S084 2016-10-05 30-day Notice
S083 2016-08-22 30-day Notice
S082 2016-08-19 Normal 180 Day Track
S081 2016-08-15 30-day Notice
S080 2016-08-11 30-day Notice
S079 2016-08-03 30-day Notice
S078 2016-07-25 30-day Notice
S077 2016-06-17 Normal 180 Day Track
S076 2016-05-25 30-day Notice
S075 2016-05-25 Special (immediate Track)
S074 2016-04-19 30-day Notice
S073 2016-02-22 30-day Notice
S072 2016-02-19 30-day Notice
S071 2015-12-28 30-day Notice
S070 2015-11-24 135 Review Track For 30-day Notice
S069 2015-11-20 30-day Notice
S068 2015-11-04 30-day Notice
S067 2015-10-22 30-day Notice
S066 2015-10-19 30-day Notice
S065 2015-07-28 30-day Notice
S064 2015-07-27 Normal 180 Day Track No User Fee
S063 2015-06-12 30-day Notice
S062 2015-06-03 30-day Notice
S061 2015-06-03 30-day Notice
S060 2015-06-03 30-day Notice
S059
S058
S057 2015-05-26 Normal 180 Day Track
S056 2015-02-26 30-day Notice
S055 2015-02-23 Special (immediate Track)
S054 2014-12-04 30-day Notice
S053 2014-11-13 Normal 180 Day Track
S052 2014-11-07 30-day Notice
S051 2014-11-03 30-day Notice
S050 2014-09-17 30-day Notice
S049 2014-08-11 Normal 180 Day Track
S048 2014-07-15 30-day Notice
S047 2014-06-16 Real-time Process
S046 2014-05-29 Normal 180 Day Track No User Fee
S045 2014-05-29 Normal 180 Day Track No User Fee
S044 2014-05-29 Special (immediate Track)
S043 2014-05-14 30-day Notice
S042 2014-05-13 30-day Notice
S041 2014-03-05 30-day Notice
S040 2014-02-26 Normal 180 Day Track
S039 2014-02-12 30-day Notice
S038 2014-02-11 30-day Notice
S037 2014-02-11 30-day Notice
S036 2014-01-22 30-day Notice
S035 2014-01-14 Normal 180 Day Track
S034 2014-01-10 30-day Notice
S033 2013-11-18 Real-time Process
S032 2013-12-06 Real-time Process
S031 2013-09-30 30-day Notice
S030 2013-09-17 30-day Notice
S029 2013-08-07 30-day Notice
S028 2013-07-05 30-day Notice
S027 2013-06-25 30-day Notice
S026 2013-06-17 Normal 180 Day Track No User Fee
S025 2013-06-17 Normal 180 Day Track No User Fee
S024 2013-06-17 Normal 180 Day Track No User Fee
S023 2013-06-03 Real-time Process
S022 2013-05-31 Special (immediate Track)
S021 2013-05-13 Normal 180 Day Track
S020 2013-05-01 Normal 180 Day Track
S019 2013-04-01 Real-time Process
S018 2013-03-04 30-day Notice
S017 2013-02-27 30-day Notice
S016
S015 2013-01-23 30-day Notice
S014 2012-12-20 Normal 180 Day Track No User Fee
S013 2012-12-05 135 Review Track For 30-day Notice
S012 2012-12-05 30-day Notice
S011 2012-12-05 30-day Notice
S010 2012-12-05 135 Review Track For 30-day Notice
S009 2012-12-03 30-day Notice
S008 2012-11-29 30-day Notice
S007 2012-11-30 30-day Notice
S006 2012-11-30 30-day Notice
S005 2012-11-29 135 Review Track For 30-day Notice
S004 2012-11-29 30-day Notice
S003 2012-11-27 30-day Notice
S002 2012-11-27 30-day Notice
S001 2012-11-27 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00888707000468 P100047 000
00888707000475 P100047 000
00888707001632 P100047 000
00888707006873 P100047 000

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