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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.
 
DeviceGUARDIAN REAL TIME MONITOR
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS168
Date Received10/31/2014
Decision Date01/28/2015
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE SUPER CAPACITOR, A COMPONENT USED ON THE INTERFACE BOARDS OF THE GUARDIAN REAL-TIME MONITORS (MODELS CSS7100 AND CSS7100K)WHICH ARE COMPONENTS OF THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM.
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