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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.
 
DeviceCONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Date Received12/15/1997
Decision Date06/15/1999
Product Codes MDS OYC 
Docket Number 99M-2169
Notice Date 07/14/1999
Advisory Committee Clinical Chemistry
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace blood glucose information obtained using standard home glucose monitoring devices. The information collected by the device may be downloaded and displayed on a computer and review by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments, which may minimize these excursions.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S006 S007 S008 S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S046 S047 S048 S049 S050 S051 S052 
S054 S055 S056 S057 S058 S059 S060 S061 S062 S064 S065 S067 
S068 S069 S070 S071 S072 S073 S075 S076 S077 S078 S079 S080 
S081 S082 S083 S085 S086 S087 S088 S089 S090 S091 S092 S093 
S095 S097 S098 S099 S100 S101 S102 S103 S104 S105 S106 S107 
S108 S109 S110 S111 S112 S113 S114 S115 S116 S117 S119 S120 
S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 S131 S132 
S133 S134 S135 S136 S137 S138 S140 S142 S143 S145 S146 S147 
S148 S149 S150 S151 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 
S186 S187 S188 S189 S190 S191 S193 S195 S197 S199 S200 S201 
S202 S203 S204 S205 S206 S207 S208 
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