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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.
 
DeviceMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS083
Date Received08/20/2010
Decision Date10/06/2010
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR MODIFICATION TO THE DESIGN OF THE PARADIGM REAL-TIME PUMP CASE (MODELS MMT-522, MMT-522K, MMT-523, MMT-523K) TO ALLOW FOR A ¿TWO SHOT¿ MOLDING TECHNOLOGY FOR THE MANUFACTURE OF THE MAIN CASE BY A NEW SUPPLIER.
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