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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
7000 central avenue ne
rcw 235
minneapolis, MN 55432-3576
HDE NumberH990014
Date Received12/06/1999
Decision Date03/31/2000
Product Code
LNQ[ Registered Establishments with LNQ ]
Docket Number 00M-1451
Advisory Committee Gastroenterology
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 S112