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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.
 
DeviceBIOSTATOR GLUCOSE CONTROLLER
Classification Namecontroller, closed-loop blood glucose
Generic Namecontroller, closed-loop blood glucose
Applicant
MILES LABORATORIES, INC.
1127 myrtle st.
p.o. box 40
elkhart, IN 46514
PMA NumberP800032
Date Received06/05/1980
Decision Date05/28/1981
Product Code
LHE
Notice Date 06/19/1981
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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