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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709)
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS026
Date Received03/06/2008
Decision Date04/23/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the minimed real-time transmitter and the cgms ipro digital recorder. The modification includes adding an esd protection diode and a few other circuit changes to the rf input/output port of the devices.
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