Genesis Neurostimulation System

Stimulator, Spinal-cord, Totally Implanted For Pain Relief

FDA Premarket Approval P010032 S155

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

Changes in the viable air sampling method and a corresponding change to the action and alert limits for the airborne microbes in the controlled access environments(cae).

DeviceGenesis Neurostimulation System
Classification NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantAbbott Medical
Date Received2019-10-21
Decision Date2019-11-19
PMAP010032
SupplementS155
Product CodeLGW
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 6901 Preston Road plano, TX 75024

Supplemental Filings

Supplement NumberDateSupplement Type
P010032Original Filing
S155 2019-10-21 30-day Notice
S154 2019-07-01 Real-time Process
S153 2019-07-01 30-day Notice
S152 2019-06-17 30-day Notice
S151
S150 2019-05-07 Normal 180 Day Track No User Fee
S149
S148 2019-01-23 Real-time Process
S147 2018-12-26 Real-time Process
S146 2018-12-17 30-day Notice
S145 2018-11-08 30-day Notice
S144 2018-10-19 30-day Notice
S143 2018-09-06 30-day Notice
S142
S141 2018-02-13 Normal 180 Day Track
S140 2017-12-18 30-day Notice
S139 2017-12-15 30-day Notice
S138 2017-11-16 30-day Notice
S137 2017-11-15 Real-time Process
S136 2017-11-13 30-day Notice
S135 2017-09-12 Normal 180 Day Track
S134 2017-09-11 Real-time Process
S133 2017-08-10 30-day Notice
S132 2017-07-28 Normal 180 Day Track No User Fee
S131
S130 2017-06-26 30-day Notice
S129 2017-06-02 30-day Notice
S128 2017-05-23 30-day Notice
S127 2016-11-07 Normal 180 Day Track
S126 2016-11-01 30-day Notice
S125 2016-10-24 Normal 180 Day Track
S124 2016-10-11 Real-time Process
S123
S122 2016-07-11 Real-time Process
S121
S120 2016-06-22 Real-time Process
S119 2016-06-13 30-day Notice
S118 2016-06-06 Normal 180 Day Track
S117 2016-04-28 30-day Notice
S116 2016-03-30 30-day Notice
S115 2016-03-21 Normal 180 Day Track
S114 2016-03-21 30-day Notice
S113 2016-02-02 30-day Notice
S112 2016-01-27 30-day Notice
S111 2016-01-19 30-day Notice
S110 2015-12-23 Real-time Process
S109 2015-12-11 Normal 180 Day Track
S108 2015-12-08 Real-time Process
S107 2015-11-09 30-day Notice
S106 2015-11-06 30-day Notice
S105 2015-10-08 30-day Notice
S104 2015-10-07 30-day Notice
S103 2015-10-06 30-day Notice
S102 2015-09-21 Real-time Process
S101 2015-09-15 30-day Notice
S100 2015-08-21 Normal 180 Day Track No User Fee
S099 2015-08-14 30-day Notice
S098 2015-08-04 Real-time Process
S097 2015-07-02 Normal 180 Day Track
S096 2015-04-02 Normal 180 Day Track
S095 2015-01-29 30-day Notice
S094 2014-12-24 Real-time Process
S093 2014-12-24 Normal 180 Day Track
S092 2014-12-19 Normal 180 Day Track
S091 2014-12-15 Normal 180 Day Track No User Fee
S090 2014-12-15 Real-time Process
S089 2014-11-21 30-day Notice
S088 2014-11-20 30-day Notice
S087 2014-11-18 Real-time Process
S086 2014-10-14 30-day Notice
S085 2014-09-29 Normal 180 Day Track
S084 2014-09-08 30-day Notice
S083 2014-07-10 Real-time Process
S082 2014-06-20 30-day Notice
S081 2014-06-11 Real-time Process
S080 2014-05-29 30-day Notice
S079 2014-04-15 Real-time Process
S078 2014-04-08 Real-time Process
S077 2014-03-06 30-day Notice
S076 2014-01-10 Real-time Process
S075 2014-01-03 Normal 180 Day Track
S074 2013-12-23 Real-time Process
S073 2013-07-29 Normal 180 Day Track No User Fee
S072 2013-06-14 30-day Notice
S071 2013-05-20 Real-time Process
S070 2013-03-11 30-day Notice
S069
S068 2013-02-19 Real-time Process
S067 2013-01-28 Real-time Process
S066 2012-12-26 Real-time Process
S065 2012-12-17 30-day Notice
S064 2012-11-07 30-day Notice
S063 2012-10-15 Normal 180 Day Track
S062 2012-08-03 30-day Notice
S061 2012-07-30 135 Review Track For 30-day Notice
S060 2012-07-20 30-day Notice
S059 2012-07-17 135 Review Track For 30-day Notice
S058 2012-07-16 Real-time Process
S057 2012-07-06 Real-time Process
S056 2012-07-02 30-day Notice
S055 2012-06-06 135 Review Track For 30-day Notice
S054 2012-06-01 Real-time Process
S053 2012-06-01 Real-time Process
S052 2012-05-31 30-day Notice
S051 2012-04-19 30-day Notice
S050 2012-04-18 135 Review Track For 30-day Notice
S049 2012-03-27 30-day Notice
S048 2012-02-15 Real-time Process
S047 2012-02-01 30-day Notice
S046
S045 2011-12-21 30-day Notice
S044 2011-12-09 30-day Notice
S043 2011-10-04 30-day Notice
S042
S041 2011-08-29 Real-time Process
S040 2011-07-18 Special (immediate Track)
S039 2011-06-20 135 Review Track For 30-day Notice
S038 2011-05-11 135 Review Track For 30-day Notice
S037 2010-12-29 Real-time Process
S036 2010-11-23 Real-time Process
S035 2010-10-21 Special (immediate Track)
S034 2010-10-20 Special (immediate Track)
S033
S032 2009-07-15 Real-time Process
S031 2009-07-01 Normal 180 Day Track
S030
S029 2009-04-02 Real-time Process
S028 2009-01-08 Normal 180 Day Track No User Fee
S027 2008-12-03 30-day Notice
S026 2008-06-10 Real-time Process
S025 2008-04-11 Real-time Process
S024 2008-01-22 Special (immediate Track)
S023 2007-10-02 Normal 180 Day Track
S022 2007-08-06 Real-time Process
S021 2007-07-13 Normal 180 Day Track
S020 2007-03-21 Real-time Process
S019 2006-01-23 Normal 180 Day Track
S018 2005-11-25 Real-time Process
S017 2005-08-30 Normal 180 Day Track
S016 2005-02-22 Real-time Process
S015
S014 2004-12-27 Real-time Process
S013 2004-12-16 Real-time Process
S012 2004-05-10 Normal 180 Day Track
S011 2004-04-09 Normal 180 Day Track No User Fee
S010 2004-03-24 Real-time Process
S009 2003-11-12 Real-time Process
S008 2003-05-28 Real-time Process
S007 2003-01-23 Normal 180 Day Track
S006 2002-11-04 Real-time Process
S005 2002-10-24 Real-time Process
S004
S003 2002-07-02 Real-time Process
S002 2002-05-14 Real-time Process
S001

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.