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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
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS114
Date Received03/05/2012
Decision Date04/04/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
USE OF AN ALTERNATIVE SUPERCAPACITOR DUE TO A SUPPLY CHAIN PROBLEM. THESUPERCAPACITOR 1037110-003 (NEC P/N: FGH0H154ZF-H5E) WILL REPLACE 1037110-002 (NECPIN: FGH0H154ZF-LE) FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, -522K,-722, -722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT -523, -523K, -723,-723K). THE PARADIGM REAL-TIME PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM. THE PARADIGM REAL-TIME REVEL PUMP IS A COMPONENT OF THEPARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM.
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