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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 NamePARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS150
Date Received12/23/2013
Decision Date03/13/2014
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 changes to the stack assemblies and battery tube assembly to comply with rohs (restriction of hazardous substances) requirements. These changes include changes to five components on the stack assembly, a change in material for the bare printed circuit boards (pcbs) of the stack assembly and battery tube assembly, and a change to the solder material (from tin/lead to tin/silver/copper) used on the pcbs.
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