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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 PUMP & PARADIGM REAL TIME REVEL INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS138
Date Received10/03/2013
Decision Date10/31/2013
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF LABELING CHANGES TO THE USER GUIDE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, AND MMT-722K), AND FOR THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEMS.
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