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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring sytem
ApplicantMEDTRONIC MINIMED
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
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