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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
Predetermined Change Control Plan AuthorizedNo
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:  S098 S093 S095 S097 S009 S012 S131 S132 S099 S100 S101 
S001 S011 S030 S031 S032 S033 S014 S027 S028 S029 S021 S006 
S008 S013 S197 S195 S199 S003 S091 S092 S010 S015 S016 S017 
S023 S024 S025 S026 S059 S060 S061 S062 S068 S069 S070 S081 
S082 S083 S085 S034 S035 S036 S037 S038 S039 S040 S041 S042 
S018 S019 S046 S047 S048 S049 S050 S051 S071 S064 S065 S086 
S087 S088 S089 S090 S052 S054 S055 S072 S073 S075 S076 S077 
S078 S079 S080 S022 S043 S191 S200 S193 S205 S204 S201 S202 
S203 S206 S208 S020 S067 S102 S103 S104 S105 S106 S107 S121 
S122 S123 S124 S161 S181 S182 S183 S184 S188 S186 S187 S189 
S138 S178 S179 S180 S157 S158 S159 S117 S125 S126 S127 S162 
S163 S164 S165 S166 S167 S168 S169 S170 S171 S172 S173 S174 
S175 S140 S142 S143 S145 S146 S147 S148 S149 S108 S133 S007 
S150 S151 S109 S110 S111 S112 S113 S119 S120 S056 S057 S058 
S134 S160 S128 S129 S130 S156 S176 S177 S207 S136 S137 S114 
S115 S116 S153 S154 S155 S135 S190 
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