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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.
 
DeviceCGMS IPRO SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS028
Date Received05/19/2008
Decision Date07/17/2008
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 THE MMT-7319 SOLUTIONS SOFTWARE FOR CGMS IPRO CONTINUOUS GLUCOSE RECORDER TO DOWNLOAD BLOOD GLUCOSE METER VALUES, OR MANUAL ENTRY OF BLOOD GLUCOSE VALUES, FROM THE LIFESCAN ULTRA 2 AND LIFESCAN ULTRALINK METERS, IN ADDITION TO THE PARADIGM LINK, LIFESCAN ULTRA AND FREESTYLE FLASH METERS.
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