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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.
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Date Received12/15/1997
Decision Date06/15/1999
Product Code
MDS[ Registered Establishments with MDS ]
Docket Number 99M-2169
Notice Date 07/14/1999
Advisory Committee Clinical Chemistry
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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