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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 SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS013
Date Received10/04/2005
Decision Date04/07/2006
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE MMT 515/715 EXTERNAL INSULIN PUMP AND TO THE GUARDIAN RT SENSOR TO ENABLE THE PUMP TO ACCEPT DATA FROM THE SENSOR, AND TO ENABLE THE SENSOR TO COMMUNICATE DIRECTLY TO THE PUMP. THE DEVICE WILL BE MANUFACTURED AT MEDTRONIC MINIMED, NORTHRIDGE, CALIFORNIA.
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