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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.
 
DeviceMINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS110
Date Received02/09/2012
Decision Date07/17/2012
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LANGUAGE AND PICTORIAL CHANGES TO THE INSTRUCTIONS FORUSE (IFU) OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002) TO MAKE IT CONSISTENT WITH THE LANGUAGE THAT IS INCLUDED IN THE CURRENTLY APPROVED PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP USER GUIDES. THE SOF-SENSOR, PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL- TIME SYSTEM, GUARDIAN REAL-TIME SYSTEM, AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSEMONITORING (CGM) SYSTEM.
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