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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 SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS148
Date Received11/08/2013
Decision Date12/05/2013
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  
PC-BASED MANUFACTURING SOFTWARE UPDATE FROM VERSION 2.2A TO VERSION 2.3A AT THE MEDTRONIC MINIMED, NORTHRIDGE FACILITY, AND UPDATE FROM VERSION 2.0D TO VERSION 2.3A AT THE MPROC, JUNCOS FACILITY FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, AND MMT-722K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K), THE GUARDIAN REAL-TIME MONITOR (MODEL: CSS7100) AND THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751).
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