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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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 NumberS108
Date Received01/24/2012
Decision Date03/30/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATIVE SUPER CAPACITOR USED ON THE INTERFACEBOARD OF 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) WHICH ARE COMPONENTS OF THE CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM.
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