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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 AND PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS113
Date Received02/27/2012
Decision Date04/18/2012
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE SUPERCAPACITOR, A COMPONENT USED ON THE INTERFACE BOARDS OF THE PARADIGM REAL-TIME PUMP (MODELS MMT-522, -522K, -722, 722K) AND PARADIGM REAL-TIME REVEL PUMP (MODELS MMT-523, -523K, -723, -723K) WHICH ARE COMPONENTS OF THE DEVICES.
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