Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

FDA Premarket Approval P010032 S161

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

To implement an updated helium leak test system software used during assembly of orion family (proclaim scs, infinity dbs, proclaim drg) implantable pulse generators (ipgs)

DeviceSpinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantAbbott Medical
Date Received2020-04-06
Decision Date2020-05-06
PMAP010032
SupplementS161
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
S163 2020-04-30 30-day Notice
S162
S161 2020-04-06 30-day Notice
S160 2020-04-06 30-day Notice
S159 2020-02-03 30-day Notice
S158 2019-12-13 30-day Notice
S157
S156
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

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