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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceVNS THERAPY SYSTEM
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Date Received01/27/1997
Decision Date07/16/1997
Product Codes LYJ MUZ 
Docket Number 98M-0140
Notice Date 03/04/1998
Advisory Committee Neurology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the NeuroCybernetic Prosthesis (NCP(R)) System which includes the Model 100 NCP Generator, the Model 300 Series NCP Vagus Nerve Stimulation Lead, the Model 400 Tunneling Tool, and NCP System Accessories.
SummarySummary of Safety and Effectiveness
Supplements: S131 S132 S133 S134 S135 S136 S137 S138 S139  S159 S160 
S161 S162 S163 S147 S186 S187 S155 S167 S154 S170 S179 S151 
S146 S055 S057 S008 S009 S048 S049 S050 S051 S052 S053 S054 
S030 S031 S032 S033 S034 S063 S064 S039 S040 S041 S042 S086 
S087 S088 S089 S090 S091 S024 S025 S072 S073 S074 S105 S106 
S116 S117 S047 S110 S111 S037 S038 S071 S014 S015 S016 S017 
S018 S019 S020 S021 S022 S062 S069 S070 S078 S079 S080 S081 
S082 S083 S084 S085 S196 S197 S198 S199 S200 S202 S203 S208 
S209 S210 S010 S011 S012 S013 S026 S027 S001 S002 S003 S004 
S005 S140 S141 S142 S166 S168 S180 S181 S182 S183 S184 S156 
S157 S158 S177 S152 S153 S172 S188 S148 S149 S150 S143 S144 
S145 S173 S175 S174 S176 S185 S164 S169 S178 S165 S045 S046 
S058 S059 S060 S065 S066 S067 S068 S035 S096 S097 S098 S100 
S112 S113 S114 S115 S109 S108 S101 S102 S075 S076 S077 S092 
S093 S094 S095 S099 S189 S190 S191 S192 S193 S194 S195 S213 
S201 S205 S206 S207 S204 S211 S103 S104 S216 S224 S231 S232 
S219 S221 S222 S233 S229 S236 S239 S240 S218 S214 S215 S223 
S225 S226 S227 S228 S234 S230 S235 S237 S238 S241 S243 S118 
S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 
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