Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: BIOSTATOR GCIIS
• Classification Name: controller, closed-loop blood glucose
• Generic Name: computerized infusion system
• Applicant: MILES LABORATORIES, INC.
• PMA Number: P790028
• Supplement Number: S002
• Date Received: 04/21/1983
• Decision Date: 08/08/1983
• Product Code: LHE
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No