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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.
 
DeviceMINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741)
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS100
Date Received10/28/2011
Decision Date07/06/2012
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR AN INCREASE IN BATTERY LEAD WIRE LENGTH AND TOLERANCES, AND INCREASE WIRE STRIPPING TOLERANCES TO MATCH WITH THE WIRE STRIP TOOL CAPABILITIES AFFECTING THE MINILINK TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, IPRO AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS.
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