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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 INSULIN INFUSINO PUMPS
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS031
Date Received08/06/2008
Decision Date03/10/2010
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE SOFTWARE MODIFICATIONS FOR MODEL MMT-523, MMT-723, MMT-523K, AND MMT-723K PARADIGM REAL-TIME INSULIN PUMPS AS WELL AS NEW VERSIONS OF CARELINK PRO AND CARELINK PERSONAL ACCESSORY SOFTWARE THAT HAVE BEEN UPDATED TO SUPPORT THESE INSULIN PUMP MODELS.
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