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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.
 
DeviceDEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS073
Date Received05/10/2010
Decision Date06/29/2010
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 A CHANGE TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES (DEV-0016). THE SOFTWARE VERSION 1.0A IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS AND CORRECTION OF THREE MINOR ANOMALIES.
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