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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namecontroller, closed-loop blood glucose
Generic Namecomputerized infusion system
PMA NumberP790028
Date Received11/16/1979
Decision Date12/04/1980
Withdrawal Date 10/05/2007
Product Code
Notice Date 02/20/1981
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002