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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Enterra Medical, Inc.
5353 wayzata blvd.
suite 400
st. louis park, MN 55416
HDE NumberH990014
Date Received12/06/1999
Decision Date03/31/2000
Product Code
LNQ[ Registered Establishments with LNQ ]
Docket Number 00M-1451
Advisory Committee Gastroenterology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The gastric electrical stimulation (ges) system is indicated for treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S013 S014 S015 S016 S018 S020 S022 S023 
S024 S025 S026 S027 S030 S032 S033 S034 S035 
S036 S037 S038 S040 S041 S042 S043 S044 S045 
S046 S047 S048 S049 S050 S051 S052 S053 S054 
S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S077 S079 S080 S081 S082 S083 
S084 S085 S086 S087 S088 S089 S090 S091 S092 
S093 S094 S095 S096 S097 S098 S099 S100 S101 
S102 S103 S104 S105 S106 S107 S108 S109 S110 
S111 S112 S113 S114 S115 S116 S117 S118 S119 
S120 S121 S122 S123 S124 S125 S126 S127 S128 
S129 S130 S131 S132 S133 S134 S135 S136 S137 
S138 S139 S140 S141 S142 S143 S144 S145 S146 
S147 S148 S149 S150 S151 S152 S153 S154 S155 
S156 S157 S158 S159 S160 S161 S162 S163 S164 
S165 S166 S167 S168 S169 S170 S171 S172 S173 
S174 S175 S176 S177 S178 S179 S180 S181 S182 
S183 S184 S185 S186 S187 S188 S189 S190 S191 
S192 S193 S194 S195 S196 S197 S198 S199 S200 
S201 S202 S203 S204 S205 S206 S207 S208 S209 
S210 S211 S212 S213 S214 S215 S216 S217 S218 
S219 S220 S221 S222 S223 S224 S226 S227