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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.
 
DeviceCARELINK IPRO THERAPY MANAGEMENT SOFTWARE
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS124
Date Received09/18/2012
Decision Date11/16/2012
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE CARELINK IPRO THERAPYMANAGEMENT SOFTWARE (MMT-7340) FROM VERSION 1.4 TO VERSION 1.5A. THE CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MMT-7340) IS A COMPONENT OF THE IPRO2 PROFESSIONAL CGM SYSTEM (MMT-7745).
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