Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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: S201 S204 S208 S206  S098 S099 S176 S177 S119 S120 S150 
S102 S103 S104 S105 S106 S107 S154 S155 S156 S135 S181 S182 
S183 S184 S188 S186 S187 S160 S128 S129 S056 S057 S058 S009 
S012 S001 S020 S011 S030 S031 S032 S033 S014 S027 S028 S029 
S067 S021 S006 S008 S013 S193 S200 S003 S093 S095 S097 S112 
S113 S114 S115 S116 S117 S121 S122 S123 S124 S130 S131 S132 
S134 S136 S137 S161 S157 S158 S159 S100 S101 S178 S179 S180 
S151 S138 S140 S142 S143 S145 S146 S147 S148 S149 S189 S125 
S126 S127 S162 S163 S164 S165 S166 S167 S168 S169 S170 S171 
S172 S173 S174 S175 S108 S109 S110 S111 S133 S153 S091 S092 
S007 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 S190 S191 
S199 S197 S195 S205 S202 S203 S207 
-
-