Premarket Approval (PMA)

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.

• 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
• Supplement Number: S001
• Date Received: 04/28/1983
• Decision Date: 06/02/1983
• Product Code: LHE
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No