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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.
 
DeviceGUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS121
Date Received08/17/2012
Decision Date09/13/2012
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REINSTATEMENT OF THE AYUTTHAYA, THAILAND FACILITY AS AN ADDITIONAL FACILITY FOR THE MANUFACTURE OF PRINTED CIRCUIT BOARD ASSEMBLIES AND STACK SUBASSEMBLIES USED BY MEDTRONIC MINIMED IN THE PRODUCTION OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K)) AND GUARDIAN REAL-TIME MONITOR (CSS7100, CSS7 100K). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, AND GUARDIAN REAL-TIME MONITOR ARE COMPONENTS OF THE DEVICES.
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