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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOSTATOR GLUCOSE CONTROLLER
Generic NameController, closed-loop blood glucose
ApplicantMILES LABORATORIES, INC.
1127 MYRTLE ST.
P.O. BOX 40
ELKHART, IN 46514
PMA NumberP800032
Supplement NumberS001
Date Received04/28/1983
Decision Date06/02/1983
Product Code LHE 
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductNo
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