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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namecontroller, closed-loop blood glucose
Generic Namecontroller, closed-loop blood glucose
430 south beiger street
mishawaka, IN 46544
PMA NumberP790028
Supplement NumberS001
Date Received10/04/1982
Decision Date11/18/1982
Product Code
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No