360 DEGREES.">

VNS THERAPY PERENNIAFLEX

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Premarket Approval P970003 S100

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 the following minor modifications to the approvedmodel 303 stimulation lead (the new model to be referred to as "304"):1) changing the coil material to one with a lower titanium tolerance (< 0. 01%) to improvefatigue resistance;2) changing the insulating material to one that is similar, but with improved fatigue andabrasion resistance;3) adding a controlled fillet to the electrode bifurcation to improve fatigue resistance, and4) adding an intermediate electrode size (2. 5 mm) that also offers nerve coverage >360 degrees.

DeviceVNS THERAPY PERENNIAFLEX
Classification NameStimulator, Autonomic Nerve, Implanted For Epilepsy
Generic NameStimulator, Autonomic Nerve, Implanted For Epilepsy
ApplicantLivaNova USA, Inc.
Date Received2008-07-24
Decision Date2008-12-19
PMAP970003
SupplementS100
Product CodeLYJ
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address LivaNova USA, Inc. 100 Cyberonics Blvd. houston, TX 77058

Supplemental Filings

Supplement NumberDateSupplement Type
P970003Original Filing
S237 2022-12-19 30-day Notice
S236 2022-04-11 Real-time Process
S235 2022-02-22 30-day Notice
S234 2020-11-12 Real-time Process
S233
S232 2020-02-28 30-day Notice
S231
S230 2019-12-06 30-day Notice
S229 2019-10-15 Real-time Process
S228
S227 2019-09-26 30-day Notice
S226 2019-06-10 Real-time Process
S225
S224 2019-04-24 30-day Notice
S223 2019-02-04 30-day Notice
S222 2019-01-15 Special (immediate Track)
S221 2018-12-27 Real-time Process
S220
S219 2018-12-17 135 Review Track For 30-day Notice
S218 2018-04-30 Real-time Process
S217
S216 2017-12-26 30-day Notice
S215 2017-12-04 Real-time Process
S214 2017-11-20 30-day Notice
S213 2017-07-19 30-day Notice
S212
S211 2017-05-02 Normal 180 Day Track
S210 2017-04-03 Normal 180 Day Track
S209 2017-01-24 30-day Notice
S208 2016-12-19 30-day Notice
S207 2016-11-17 Panel Track
S206 2016-11-07 30-day Notice
S205 2016-11-04 Normal 180 Day Track
S204 2016-08-11 30-day Notice
S203 2016-07-15 30-day Notice
S202 2016-07-13 Special (immediate Track)
S201 2016-07-01 30-day Notice
S200 2016-05-23 Normal 180 Day Track No User Fee
S199 2016-05-09 30-day Notice
S198 2016-05-06 Normal 180 Day Track No User Fee
S197 2016-05-03 Normal 180 Day Track
S196 2016-04-18 Real-time Process
S195 2016-03-11 Normal 180 Day Track No User Fee
S194 2016-02-24 30-day Notice
S193 2016-02-23 30-day Notice
S192 2016-02-22 30-day Notice
S191 2016-02-17 30-day Notice
S190 2016-02-04 Real-time Process
S189 2016-01-29 Special (immediate Track)
S188 2015-11-24 Real-time Process
S187 2015-10-27 30-day Notice
S186 2015-10-09 30-day Notice
S185 2015-08-31 30-day Notice
S184 2015-07-29 30-day Notice
S183 2015-07-29 Real-time Process
S182 2015-07-01 Normal 180 Day Track
S181 2015-06-22 30-day Notice
S180 2015-06-08 30-day Notice
S179 2015-05-26 Real-time Process
S178 2015-03-23 30-day Notice
S177 2015-03-12 30-day Notice
S176 2014-12-09 Real-time Process
S175 2014-11-17 30-day Notice
S174 2014-11-17 Normal 180 Day Track No User Fee
S173 2014-10-23 Normal 180 Day Track
S172 2014-06-19 30-day Notice
S171
S170 2014-04-28 Normal 180 Day Track No User Fee
S169 2014-04-04 Real-time Process
S168 2014-02-26 30-day Notice
S167 2013-12-03 30-day Notice
S166 2013-11-01 Normal 180 Day Track
S165 2013-08-12 30-day Notice
S164 2013-06-26 Real-time Process
S163 2013-04-23 30-day Notice
S162 2013-04-22 Real-time Process
S161 2013-04-05 30-day Notice
S160 2013-03-14 30-day Notice
S159 2013-03-11 30-day Notice
S158 2013-02-01 Real-time Process
S157 2013-01-24 Real-time Process
S156 2013-01-17 30-day Notice
S155 2012-11-19 135 Review Track For 30-day Notice
S154 2012-11-06 Real-time Process
S153 2012-10-01 30-day Notice
S152 2012-08-17 30-day Notice
S151 2012-08-07 30-day Notice
S150 2012-07-02 30-day Notice
S149 2012-06-06 30-day Notice
S148 2012-05-24 Real-time Process
S147 2012-03-14 30-day Notice
S146 2012-03-08 Normal 180 Day Track No User Fee
S145 2012-01-13 30-day Notice
S144 2012-01-06 30-day Notice
S143 2011-12-19 30-day Notice
S142 2011-12-02 30-day Notice
S141 2011-11-03 30-day Notice
S140 2011-10-21 Real-time Process
S139 2011-10-11 30-day Notice
S138 2011-09-30 30-day Notice
S137 2011-09-21 30-day Notice
S136 2011-09-20 30-day Notice
S135 2011-09-01 Real-time Process
S134 2011-08-11 30-day Notice
S133 2011-08-01 30-day Notice
S132 2011-07-05 30-day Notice
S131 2011-07-12 30-day Notice
S130 2011-06-27 Real-time Process
S129 2011-06-20 30-day Notice
S128 2011-06-13 30-day Notice
S127 2011-05-04 30-day Notice
S126 2011-04-20 30-day Notice
S125 2011-03-31 30-day Notice
S124 2011-03-16 135 Review Track For 30-day Notice
S123 2011-02-25 30-day Notice
S122 2011-01-31 30-day Notice
S121 2011-01-27 30-day Notice
S120 2011-01-24 30-day Notice
S119 2010-11-22 Real-time Process
S118 2010-11-19 30-day Notice
S117 2010-11-12 Normal 180 Day Track No User Fee
S116 2010-09-27 Real-time Process
S115 2010-09-21 Real-time Process
S114 2010-09-13 30-day Notice
S113 2010-08-11 30-day Notice
S112 2010-07-22 Real-time Process
S111 2010-06-22 Normal 180 Day Track No User Fee
S110 2010-05-27 135 Review Track For 30-day Notice
S109 2010-04-19 Special (immediate Track)
S108 2009-11-09 Special (immediate Track)
S107
S106 2009-02-05 Normal 180 Day Track No User Fee
S105 2009-01-26 30-day Notice
S104 2008-11-26 Normal 180 Day Track No User Fee
S103 2008-10-31 Real-time Process
S102 2008-10-01 Special (immediate Track)
S101 2008-09-29 30-day Notice
S100 2008-07-24 Real-time Process
S099 2008-05-27 135 Review Track For 30-day Notice
S098 2008-02-04 Real-time Process
S097 2008-02-01 30-day Notice
S096 2008-01-23 Special (immediate Track)
S095 2007-11-21 Special (immediate Track)
S094 2007-11-19 30-day Notice
S093 2007-11-23 Real-time Process
S092 2007-10-16 30-day Notice
S091 2007-09-27 Normal 180 Day Track No User Fee
S090 2007-09-24 Normal 180 Day Track No User Fee
S089 2007-09-10 Special (immediate Track)
S088 2007-08-24 30-day Notice
S087 2007-08-17 30-day Notice
S086 2007-08-02 Real-time Process
S085 2007-06-11 Normal 180 Day Track No User Fee
S084 2007-05-29 30-day Notice
S083 2007-05-24 Normal 180 Day Track No User Fee
S082 2007-05-18 Special (immediate Track)
S081 2007-04-30 Special (immediate Track)
S080 2007-04-13 30-day Notice
S079 2007-04-13 Real-time Process
S078 2007-03-27 Special (immediate Track)
S077 2007-03-15 Normal 180 Day Track No User Fee
S076 2007-01-22 Normal 180 Day Track
S075 2006-12-15 Normal 180 Day Track No User Fee
S074 2006-10-10 Special (immediate Track)
S073 2006-10-06 30-day Notice
S072 2006-10-06 30-day Notice
S071 2006-08-24 Real-time Process
S070 2006-07-17 Real-time Process
S069 2006-07-12 Normal 180 Day Track No User Fee
S068 2006-06-16 Normal 180 Day Track
S067 2006-05-26 30-day Notice
S066 2006-04-17 Real-time Process
S065 2006-03-01 Real-time Process
S064 2006-02-01 Real-time Process
S063 2006-01-27 Real-time Process
S062 2005-11-07 Real-time Process
S061
S060 2005-08-31 Normal 180 Day Track No User Fee
S059 2005-08-12 Normal 180 Day Track No User Fee
S058 2005-07-20 Special (immediate Track)
S057 2005-03-30 Special (immediate Track)
S056
S055 2004-11-08 Real-time Process
S054 2004-02-06 30-day Notice
S053 2004-02-02 30-day Notice
S052 2003-12-08 30-day Notice
S051 2004-02-24 Normal 180 Day Track
S050 2003-10-27 Panel Track
S049 2003-10-21 Special (immediate Track)
S048 2003-09-17 Special (immediate Track)
S047 2003-06-20 Real-time Process
S046 2002-11-29 Normal 180 Day Track
S045 2002-10-24 Real-time Process
S044
S043
S042 2002-05-01 Real-time Process
S041 2002-04-29 Real-time Process
S040 2002-04-19 Real-time Process
S039 2002-04-17 Real-time Process
S038 2002-02-08 Real-time Process
S037 2002-01-10 Real-time Process
S036
S035 2001-08-27 Special (immediate Track)
S034 2001-05-21 Real-time Process
S033 2001-05-07 Special (immediate Track)
S032 2001-03-23 Normal 180 Day Track
S031 2001-03-19 Real-time Process
S030 2001-01-26 Real-time Process
S029
S028
S027 2000-08-07 30-day Notice
S026 2000-06-01 Real-time Process
S025 1999-12-27 Real-time Process
S024 1999-12-03 Special (immediate Track)
S023
S022 1999-04-01 Real-time Process
S021 1999-03-19 30-day Notice
S020 1999-03-19 30-day Notice
S019 1999-03-19 30-day Notice
S018 1999-01-19 Real-time Process
S017 1999-01-04 30-day Notice
S016 1999-01-04 Real-time Process
S015 1998-12-28 Normal 180 Day Track
S014 1998-12-21 Special (immediate Track)
S013 1998-12-04 Real-time Process
S012 1998-11-17 Real-time Process
S011 1998-10-01 30-day Notice
S010 1998-09-14 30-day Notice
S009 1998-02-19 30-day Notice
S008 1998-02-19 30-day Notice
S007
S006
S005 1997-09-16 Real-time Process
S004 1997-09-18 Real-time Process
S003 1997-09-18 Normal 180 Day Track
S002 1997-09-04 Real-time Process
S001 1997-08-07 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05425025750160 P970003 016
05425025750245 P970003 039
05425025750016 P970003 040
05425025750092 P970003 040
05425025750108 P970003 040
05425025750023 P970003 047
05425025750122 P970003 064
05425025750115 P970003 064
05425025750047 P970003 076
05425025750030 P970003 076
05425025750153 P970003 100
05425025750139 P970003 100
05425025750054 P970003 119
05425025750184 P970003 148
05425025750191 P970003 148
05425025750214 P970003 154
05425025750382 P970003 154
05425025750368 P970003 173
05425025750061 P970003 173
05425025750375 P970003 183
05425025750405 P970003 210
05425025750177 P970003 210
05425025750399 P970003 211
05425025750481 P970003 215
05425025750429 P970003 218
05425025750511 P970003 225
05425025750504 P970003 226
05425025750443 P970003 226
05425025750528 P970003 231
05425025750535 P970003 234
05425025750634 P970003 241
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.