Premarket Approval (PMA)

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.

• Device: BIOSTATOR GLUCOSE CONTROLLER
• Generic Name: Controller, closed-loop blood glucose
• Applicant: MILES LABORATORIES, INC.; 1127 MYRTLE ST.; P.O. BOX 40; ELKHART, IN 46514
• PMA Number: P800032
• Date Received: 06/05/1980
• Decision Date: 05/28/1981
• Product Code: LHE
• Notice Date: 06/19/1981
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001