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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 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.
Classification Namecontroller, closed-loop blood glucose
Generic Namecontroller, closed-loop blood glucose
430 south beiger street
mishawaka, IN 46544
PMA NumberP790028
Supplement NumberS002
Date Received04/21/1983
Decision Date08/08/1983
Product Code
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No