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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.
 
DeviceSOF-SENSOR GLUCOSE SENSORS
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS061
Date Received09/29/2009
Decision Date11/05/2009
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE REPLACEMENT OF THE CURRENT SOF-SENSOR GLUCOSE SENSOR MMT-7002 AND MMT-7003 POUCH WITH A SIMILAR ONE BY SUPPLIER TOLAS HEALTHCARE. THE DIFFERENCE BETWEEN THE TWO POUCHES IS THAT THE BOTTOM WEB OF THE POUCH IS CHANGED FROM P/N TPF-0521 TO P/N TPF-0521 NC DUE TO THE CHANGE OF THE SUPPLIER FOR TOLAS HEALTHCARE.
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