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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.
 
DeviceCGMS GOLD MONITOR (MMT-7102W)
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS101
Date Received11/01/2011
Decision Date12/28/2011
Product Code MDS 
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 THE GLASS-LIDDED CRYSTAL TO BE REPLACED WITH A CERAMIC LIDDED CRYSTAL ON THE DIGITAL BOARD IN THE GOLD MONITOR (MODEL MMT-7102W), WHICH IS A COMPONENT OF THE DEVICE.
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