Premarket Approval (PMA)

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 Name: BIOSTATOR GLUCOSE CONTROLLER
• Classification Name: controller, closed-loop blood glucose
• Generic Name: infusion system, computerized
• Applicant: MILES LABORATORIES, INC.
• 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