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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.
 
DevicePARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS150
Date Received12/23/2013
Decision Date03/13/2014
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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