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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 PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS129
Date Received11/15/2012
Decision Date02/11/2013
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for substituting the current pvc insulation material of the vibrator motor wiring of the paradigm real-time and paradigm real-time revel insulin pumps (model numbers: mmt-522, mmt-522k, mmt-523, mmt-523k, mmt-722, mmt-722k, mmt-723, and mmt-723k) with halogen-free material.
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