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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
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS103
Date Received11/14/2011
Decision Date06/19/2012
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO INCORPORATE THE ADDITION OF PROCESS WATER TO A USED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF SENSOR GLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME SYSTEM, THE GUARDIAN REAL-TIME SYSTEM, THE CGMS IPRO SYSTEM AND THE CGMS IPRO2 SYSTEM.
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