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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 NumberS173
Date Received11/26/2014
Decision Date12/19/2014
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REPROGRAMMING OF NEW PC BOARDS/ STACKS FOR 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, MMT-723K), AND MINIMED 530GINSULIN PUMP (MODELS: MMT-551, MMT-751) IN MEDTRONIC PUERTO RICO OPERATIONS CO.(MPROC). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULINPUMP, AND MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY.
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